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Catalog Number UNKNOWN |
Device Problem
Split (2537)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant: guidewire ang stiff.035x260 glide, guidewire j tip.035x180, cath.035x135 trailblazer, cath balloon otw 5x100x135 evcr, cath sos omni 80x.35 5fr 404, stent bilry 5x17x80 visi-pro, and stent bilry 6x120x120 everflex.(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
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Event Description
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The reporter stated that during a left femoral arteriogram with renal and sfa stenting, the ansel guiding sheath tore 2 1/2 inches from the tip in a straight line.The sheath had been placed for a left femoral approach.This tear happened to the sheath during removal of the sheath.It was unknown if there was any calcification.There was no part of the device left inside of the patient.It was reported that there were no adverse effects to the patient.
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Manufacturer Narrative
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Report source: health professional corrected information: occupation.Investigation - evaluation : a review of the dimensional verification, documentation, drawing, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.The used sheath was returned, but no dilator was present.A kink is present in the sheath tubing at 17.4 cm from the proximal hub.The tubing is separated at 46.3 cm from proximal hub but still connected by exposed coil.The entire length of the device was measured to be 54.5 cm.The separation site was examined and the length of the different materials was measured.It was determined that the sheath had separated at the proximal bond.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
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Search Alerts/Recalls
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