MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G44154
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = inventory manager.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.
Event or Problem Description
As reported, upon successful completion of a peripheral crossover intervention, a flexor ansel guiding sheath unraveled upon removal of the device.Access was obtained in the femoral artery, and a contralateral approach was used to target the external iliac.Mild calcification was noted.It is unknown if resistance was encountered upon insertion or removal of the sheath.Upon removal, the sheath began to unravel mid-shaft.The dilator was not reinserted prior to removal, and was not in place at the time of unraveling.The sheath, which did not fully separate, was able to be manually removed from the patient in one piece.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, upon successful completion of a peripheral crossover intervention, a flexor ansel guiding sheath unraveled upon removal of the device.Access was obtained in the femoral artery, and a contralateral approach was used to target the external iliac.Mild calcification was noted.It is unknown if resistance was encountered upon insertion or removal of the sheath.Upon removal, the sheath began to unravel mid-shaft.The dilator was not reinserted prior to removal, and was not in place at the time of unraveling.The sheath, which did not fully separate, was able to be manually removed from the patient in one piece.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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 (dhr), the instructions for use, manufacturing instructions, and quality control data.The complainant returned one used, damaged flexor ansel guiding sheath to cook for investigation.The shaft was unraveled at approximately 16cm from the white cap and was held together by the inner coil.The distal tip was kinked at 1cm and was out of round.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.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ based on the available information, cook has concluded that operational factors contributed to this incident.The dilator was not inserted into the sheath prior to its removal from the patient, contrary to the warnings of the ifu.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 13940033
• Report Number: 1820334-2022-00482
• Device Sequence Number: 4792557
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)250104(10)14451663
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2025
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 14451663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown