It was reported that during retrieval of a celect platinum inferior vena cava (ivc) filter, after several attempts to capture the filter with both the gunther tulip vena cava filter retrieval set 9 fr and 11 fr sheaths, the valve on the 11 fr sheath separated from the sheath tubing.The physician then proceeded to unlatch the snare from the filter hook, and exchanged the set for a new gunther tulip vena cava filter retrieval set.Several additional attempts were made to capture the filter but were unsuccessful due to significant endothelialization.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Investigation ¿ evaluation: a review of the complaint history, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the hub had slipped the flare of the introducer sheath.A similar test fitting was attached to the complaint sheath, but when pulled, the fitting did not slip the sheath.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
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