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No device, no medical records, or no medical images were provided to the manufacturer.
The lot number for the device was provided.
The device history records are currently under review.
The investigation of the reported event is currently underway.
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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Manufacturing review: the device history records were 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.
This is the only event reported to date for this lot number and failure mode.
Visual/microscopic inspection: the device was returned with the product packaging and label.
The caudal anchor was returned bent.
No bowing or skiving in the storage tube was noted during evaluation.
The pusher catheter was kinked approximately 29.
1cm from the proximal end of the handle.
The kink is likely the result of the manner in which the device was packaged for return.
No kinks were reported by the user.
The dilator and sheath were not returned.
Functional/performance evaluation: the filter was returned separate from the delivery system; therefore, no functional testing was performed.
Dimensional evaluation: all measurements of the filter met the required specifications.
Medical records review: medical records were not provided for review.
Image/photo review: medical images were not provided for review.
Conclusion: the device was returned.
The investigation was inconclusive due to the filter being outside the delivery system upon return.
Based upon the available information, the definitive root cause for this event was unknown.
It was unknown if procedural factors contributed to the reported event.
Labeling review: the current ifu (instructions for use) states: warning: 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.
Precautions: it is very important to maintain introducer patency with a saline flush to prevent occlusion of the introducer, which may interfere with delivery device advancement.
Care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided.
Do not deliver the filter by pushing it beyond the end of the introducer sheath.
To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath.
Do not twist the pusher handle at anytime during this procedure.
Directions for use: implantation: inspect the packaging to ensure that it has not been opened or damaged.
Flush the introducer sheath intermittently by hand to maintain introducer sheath patency.
Maintaining patency helps prevent clot from interfering with filter deployment.
Flush the delivery device with saline through the tuohy-borst adapter.
Attach the free end of the filter storage tube directly to the introducer sheath already in the vein.
The introducer sheath and filter delivery system should be held in a straight line to minimize friction.
Loosen the proximal end of the tuohy-borst adapter and advance the filter by moving the pusher forward through the introducer sheath.
Do not twist or retract the pusher at anytime during the procedure.
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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