The FDA has communicated a notification informing users about the revisions made by Boston Scientific (NYSE: BSX) to the instructions for their PolarX cryoablation catheters. This measure involves updating the instructions for use (IFU), rather than withdrawing the product from the market. However, the FDA has classified this as the most severe category of recall due to the potential risk of serious harm or fatalities.
Boston Scientific’s revised IFU links back to a warning issued in October, concerning the PolarX and PolarX FIT cryoablation catheters. These devices form part of the PolarX cryoablation system, intended for use with the SmartFreeze console. The technology is designed to treat persistent, symptomatic atrial fibrillation (AFib).
Based in Marlborough, Massachusetts, Boston Scientific made these IFU updates after receiving an unexpectedly high number of reports concerning esophageal injuries. Specifically, the firm documented instances of atrio-esophageal fistula following catheter ablation treatments for AFib. Usage of the affected catheters could cause cerebral air embolism (air bubbles obstructing brain blood vessels), gastrointestinal bleeding, septic shock (system-wide infection), and possibly death. Boston Scientific recorded seven incidents involving injury and four fatalities related to these complications.
The IFU updates draw attention to the dangers of atrio-esophageal fistula and propose strategies to mitigate this risk, citing factors like the cryoablation application’s location, frequency, and intensity as potential contributors to the condition.
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