Age at the time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The balloon was loosely folded with blood in the balloon and lumen.The tip, balloon, and markerbands were microscopically inspected.Inspection revealed a burst in the balloon material, 63mm in length.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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