Catalog Number 1014254-060 |
Device Problems
Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/12/2019 |
Event Type
malfunction
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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 during advancement of the armada 18 3 x 60 mm over the guide wire outside the patient, there was significant kinking of the shaft and a perforation of the shaft proximal to the balloon radiopaque marker.The device was removed.There was no reported adverse patient effect or a clinically significant delay in the procedure.A non-abbott balloon was used to successfully completed the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number: (b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The kink was confirmed.The torn shaft was not 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 revealed no other incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The kinked balloon likely occurred during the attempt to advance on the geode wire.There was no perforation of the shaft as reported; however, the kink in the inner member near the proximal marker was likely mistaken for a perforation of the shaft.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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