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As reported, after gaining femoral access and using a micropuncture transitionless stiffened cannula access set, the device broken into two pieces while on the wire.The device was being used to facilitate a larger wire insertion.There was no resistance noted.There was also no scarring or calcification noted at the access site.No kinking of the wire was noted.The separation occurred during the removal.A new one (same product) was opened and used to complete the procedure.No unintended portion of the device remained inside of the patient's body.No additional procedures were required.No adverse effects were reported due to the alleged malfunction.
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Description of event: as reported, after gaining femoral access and using a micropuncture transitionless stiffened cannula access set, the device broken into two pieces while on the wire.The device was being used to facilitate a larger wire insertion.There was no resistance noted.There was also no scarring or calcification noted at the access site.No kinking of the wire was noted.The separation occurred during the removal.A new one (same product) was opened and used to complete the procedure.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The complainant returned the complaint device to cook for investigation.Physical examination of the returned device showed: one used mpis set was received.The mpis outer catheter was received in two sections.The separation point was clean and smooth, appearing to have been cut.No wire guide was returned.No additional damage was noted.As the affected component is supplied to cook, a supplier investigation will be requested.Supplier investigation: the investigation found that the affected component is supplied to cook from an external supplier.Cook requested that the supplier investigate this occurrence.The supplier investigation found: ¿the failure mode presented in the pictures is not consistent with the appearance of samples after tensile testing.This product typically elongates more than 700% prior to failure.There is not an elongation specification on this product, only a minimum tensile load.The lots in question, had an average tensile load of 2.89 pounds, with the specification being 2.25 pounds.The nature of this failure mode indicates that the tubing was compromised either by being nicked or bent prior to removing from the patient.Cpt lot j17951568332 had 31 pieces scrapped for bent tubing.Lot j17951568219 has 6 pieces scrapped for tube pinch.It appears that a defect in the tubing resulted in a failure during the procedure.We cannot determine when the defect in the tubing occurred, at cpt or in subsequent handling at cook inc.Or in the field.¿ a review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, and cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded the procedure possibly contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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