Device Problems
Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/01/2014 |
Event Type
Injury
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Event Description
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It was reported that during a scheduled vena cava filter retrieval procedure, a snare device was used to successfully capture and retrieve the filter; however, a filter arm became detached during the filter retrieval procedure.The detached arm embedded in the ivc wall was retrieved successfully.There is no reported patient injury.
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Manufacturer Narrative
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The lot number was not provided, therefore, the device history records could not be reviewed.The investigation is currently underway.
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Manufacturer Narrative
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A manufacturing review could not be conducted as the investigation lot number is unk.The filter was returned and evaluated.The filter contained 6 legs / feet and 5 arms.The filter exhibited one detached arm (w/shoulder anchor) approximately 0.5mm from the apex.The detached arm was returned with the filter.The detached arm segment measured approximately 2.6cm in length.The detached arm segment measured approximately 2 6cm in length.The break appeared to be uneven and jagged.The complaint investigation is confirmed for a filter arm detachment (w/shoulder anchor).Based upon the available information, the definitive root cause for this event is unknown.It is unknown if procedural factors contributed to the reported event.The current ifu (instructions for use) states: warnings / potential complications; filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and / or surgical techniques.
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Manufacturer Narrative
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A secondary intervention was required to retrieve the filter limb which detached during the retrieval of the filter with a snare device.There was no known impact or consequence to pt.After further clinical review of this event with bard's medical dept, this event was reassessed and determined to be mdr reportable as a serious injury pursuant to 21 cfr part 803.
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Manufacturer Narrative
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To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility did not have any additional details to provide at this time.
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Search Alerts/Recalls
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