It was reported that during an angioplasty procedure in the distal outflow vein of the fistula, the pta balloon allegedly ruptured.It was further reported that the balloon became stuck in the sheath upon removal and excessive force was used to remove the balloon causing the balloon to detach from the catheter shaft.Reportedly, the detached segment was removed and the vessel stretched due to excessive force.The physician sutured the vessel and conclude the procedure.There was no reported patient injury.
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H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the device was returned for evaluation.The sample appeared to be bloody and was returned in a sheath with the distal tip buckled that was noted under magnification.The distal end of the balloon was noted to be prolapsed over the distal tip and bunching was noted to the balloon.The balloon to catheter shaft joint was noted to be broken at the proximal end but was still attached to the device through the inner guidewire lumen.The glue bullet was noted to be pulled from its original position under magnification.No other anomalies were noted to the device.No functional testing could be performed due to the nature of the device.Therefore, the investigation is confirmed for the reported retraction problem, as the device was returned stuck inside the introducer sheath and buckling was noted to the sheath.The investigation is confirmed for the reported balloon shaft bond failure, as the balloon shaft bond was noted to be broken and the balloon was noted to be prolapsed.The investigation is inconclusive for the reported balloon rupture, as the rupture could not be tested for during evaluation.The definitive root cause for the reported balloon rupture, retraction problem and the balloon joint failure could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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It was reported that during an angioplasty procedure in the distal outflow vein of the fistula, the pta balloon allegedly ruptured.It was further reported that the balloon became stuck in the sheath upon removal and excessive force was used to remove the balloon causing the balloon to detach from the catheter shaft.Reportedly, the detached segment was removed and the vessel stretched due to excessive force.The physician sutured the vessel and conclude the procedure.There was no reported patient injury.
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