Model Number B2070-040 |
Device Problems
Material Rupture (1546); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 performed to treat a lesion with mild calcification, mild tortuosity, and 80% stenosis in the arteriovenous fistula.Although no resistance noted during advancement, a 7.0 x 40mm armada 35 balloon ruptured during first inflation at rated burst pressure.The balloon dilatation catheter was withdrawn without resistance; however, the proximal shaft separated into two pieces after being removed from the anatomy.Another same size armada 35 balloon was used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initial report, additional reported information indicates that the distal balloon separated into two pieces following the rupture and after being removed from the patient's anatomy (not the proximal shaft as previously reported).No additional information was provided.
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Manufacturer Narrative
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Visual and scanning electron microscopy (sem) analysis was performed on the returned unit.The balloon rupture and separation were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.Based on the information provided, the balloon rupture and separation appear to be due to case circumstances.It is likely that the balloon was damaged during the insertion process into the arteriovenous fistula, leading to the rupture and radial tear.The subsequent separation was likely induced during removal.The inner member separation and tip separations are related to the circumstances of the procedure.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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