The device history records have been reviewed with special attention to the (b)(4) materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned for evaluation.A visual inspection found frayed fibers on the balloon.Additionally, when the device was inflated, a pinhole rupture was noted.Therefore, the investigation is confirmed for frayed fibers and for a pinhole rupture.Per the reported event details, the target lesion was calcified, and a wall stent was present during the procedure.Therefore, it is possible that patient and/or procedural issues contributed to the event.However, the definitive root cause for the identified failures could not be determined based upon available information.The device is labeled for single use.
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This report summarizes one(1) malfunction event.A review of the events indicated that model at75186 pta balloon dilatation catheter during an angioplasty procedure of a calcified lesion in the left common iliac vein, the pta balloon allegedly ruptured at 10atm during the third inflation attempt.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.This report was received from one source.This event involved one female patient, (b)(6) years of age weighing (b)(6) lbs.There was no reported patient injury.
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