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Catalog Number DL900F |
Device Problems
Kinked (1339); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2014 |
Event Type
malfunction
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Manufacturer Narrative
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A further review of this event was performed and identified a change in the mdr reportability pursuant to 21 cfr part 803.Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: one denali femoral filter delivery system without the dilator and pusher catheter was returned for evaluation.The introducer sheath segment containing the marker band had three kinks located at 9.1cm, 11.5cm, and 16.6cm from the distal tip.The distal tip of the introducer sheath was slightly buckled.The introducer sheath segment containing the introducer sheath hub was returned disconnected from the storage tube and the filter was returned inside the sheath body, near the proximal end of the cut sheath.The filter hook is located approximately 0.7cm from the cut end of the introducer sheath.No skiving was observed on the introducer sheath segments or within the storage tube.No other anomalies were identified.Functional/performance evaluation: the filter was removed from the introducer sheath.The removed filter contained all 6 legs and 6 arms which were present and intact.No skiving was observed inside the introducer sheath segment.The hub of the returned introducer sheath was sliced open longitudinally and there were no gaps or skiving present.Heat was applied and the filter took the appropriate shape.Measurements were conducted and all measurements met the required specifications.Medical records review_ image/photo review: medical records were not provided.No images or photos were provided.Conclusion: the complaint investigation is confirmed for the filter failing to advance through the introducer sheath.The complaint investigation is also confirmed for a kinked introducer sheath.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.Labeling review: the current denali filter ifu (instructions for use) states in part: delivery of the denali filter through the introducer sheath is advance only.Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.Do not twist the pusher handle at anytime during this procedure.Additional precautions and specific directions for use of the denali filter are included in the ifu.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that during a vena cava filter deployment procedure, while advancing the filter through the deployment sheath the filter became stuck, no attempt to deploy the filter was made.The vena cava filter system was exchanged for a new vena cava filter that was prepped and deployed successfully.There is no reported patient injury.
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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 facility was able to provide new patient information, which was updated in the appropriate sections.
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Search Alerts/Recalls
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