Catalog Number B1080-080 |
Device Problems
Detachment Of Device Component (1104); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat an 80% stenosed dialysis shunt.An armada 35 balloon dilatation catheter (bdc) was used at a high pressure for dilatation; however, the balloon ruptured during the first inflation.Part of the balloon and the tip of the catheter separated and were lost in the patient.Surgery was performed to remove the separated portions.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Correction: manufacturing site.Evaluation summary: visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined that the reported difficulties were due to case circumstances.It is likely that the balloon rupture was the result of interaction with the lesion site which was described as concentric with 80% restenosis.The separation likely occurred due to the ruptured balloon material catching on the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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Search Alerts/Recalls
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