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As reported, at the beginning of an unknown procedure, a catheter included with a catheter access percutaneous entry needle separated into two pieces as another manufacturer's wire guide was being withdrawn, prior to introducer insertion.The separated portion of the catheter migrated to the left iliac artery.Operating time was extended, and local anesthetic was administered for surgical removal of the separated fragment, using larger "heavy-duty" introducers and a lasso.The fragment was successfully retrieved from the patient.There have been no reported adverse effects to the patient.
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Blank fields on this form indicate the information is unknown or unavailable.It is unknown if the device will be returned.Customer name and address= phone: (b)(6).Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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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H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, at the beginning of an aorto-femoral bypass via access in the femoral artery, a catheter included with a catheter access percutaneous entry needle separated into two pieces upon withdrawal of the device over another manufacturer's wire.The device was not advanced through a previously placed closure device.The separated portion of the catheter migrated to the left iliac artery.Operating time was extended, and local anesthetic was administered for surgical removal of the separated fragment, using larger "heavy-duty" introducers and a lasso.The fragment was successfully retrieved from the patient.There have been no reported adverse effects to the patient.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, and quality control procedures and a visual inspection of the device were conducted during the investigation.A 1.5 cm segment of an adn-18-7.0 with a pink hub was returned for investigation.The remainder of the device was not returned.The device was forwarded to the supplier for further investigation.The catheter appeared clearly torn in half.A review of device history records performed by the supplier showed no deviation or nonconformance reported during the manufacturing process of this lot that could have contributed to the failure mode reported.A review of the internal manufacturing device record and raw material history files for the reported lot number was also conducted, and no recorded quality problems or rejections related to this incident were found.Before placing the tubes in the molding fixture, the tubes are visually inspected for defects such as damage, burrs, impact, or contamination.Once the hub is formed, a 100% visual inspection is carried out in search of burrs, deformation or damage caused by the mold itself.After the perforation process, the device is further inspected for compliance with specifications.The supplier could not identify a root cause for the device problem.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a risk assessment review, no further action is required.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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