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As initially reported, during an endovascular treatment procedure, a cxi support catheter was difficult to advance, and the tip became damaged.An ipsilateral approach was used from the right femoral artery to treat a lesion in the right common iliac artery.An unknown 6 french sheath was used as well as an unknown 0.035 inch wire guide.The anatomy was not reported to be tortuous or calcified; however, resistance was reported during advancement.The user attempted to pass through the lesion several times by pushing the complaint device; however, the catheter would not cross the lesion.The user removed the device and another cxi was used to complete the procedure.Upon receipt and initial evaluation of the device on 11jun2020, the distal tip was found to be flared and frayed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as initially reported, during an endovascular treatment procedure, a cxi support catheter was difficult to advance, and the tip became damaged.An ipsilateral approach was used from the right femoral artery to treat a lesion in the right common iliac artery.An unknown 6 french sheath was used as well as an unknown 0.035-inch wire guide.The anatomy was not reported to be tortuous or calcified; however, resistance was reported during advancement.The user attempted to pass through the lesion several times by pushing the complaint device; however, the catheter would not cross the lesion.The user removed the device and another cxi was used to complete the procedure.Upon receipt and initial evaluation of the device on 11jun2020, the distal tip was found to be flared and frayed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, dimensional verification, and a visual inspection of the complaint device was conducted during the investigation.The complaint device was returned to cook for investigation.The distal tip was confirmed to be flared out/frayed and multiple kinks were noted in the shaft.No other damage was noted.A document-based investigation evaluation was performed.One failure-related nonconformance was noted; however affected units were scrapped.There is a 100% inspection for the nonconformance.There have been no other reported complaints for this lot number.From the information provided upon review of the dmr, dhr, dhf, ifu, and returned device, cook could not conclude that the device was manufactured out of specification, or that there are nonconforming devices in-house or in the field.The product ifu states: ¿the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ based on the information provided and the results of the investigation, cook has concluded that a component failure without manufacturing or design deficiency contributed to the failure mode.The risk analysis for this failure mode was reviewed and no escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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