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

Catalog Number	KCFW-7.0-18/38-45-RB-ANL1-HC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, during a procedure involving treatment of occlusive peripheral artery disease in the right leg, the hub of a flexor ansel guiding sheath separated from the device.A cook balloon and another manufacturer's wire were used during the procedure.Access was obtained in the left common femoral artery and a contralateral approach was used to target the right superficial femoral artery.The access site was not scarred, the aortic bifurcation was not steep or calcified, and the anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered upon insertion or removal of the sheath, or during insertion or removal of other devices through the sheath.After using the balloon, it was completely deflated and the user attempted to remove the balloon through the sheath; however, the hub of the sheath separated, resulting in blood leakage from the sheath.The physician stopped the blood leak, using his hand, and subsequently removed and exchanged the sheath.The new sheath was used to continue the procedure, involving treatment of a lesion below-the-knee.Per the user, "not too much" blood was lost; therefore, the patient did not require any treatment for blood loss.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving treatment of occlusive peripheral artery disease in the right leg, the hub of a flexor ansel guiding sheath separated from the device.A cook balloon and another manufacturer's wire were used during the procedure.Access was obtained in the left common femoral artery and a contralateral approach was used to target the right superficial femoral artery.The access site was not scarred, the aortic bifurcation was not steep or calcified, and the anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered upon insertion or removal of the sheath, or during insertion or removal of other devices through the sheath.After using the balloon, it was completely deflated and the user attempted to remove the balloon through the sheath; however, the hub of the sheath separated, resulting in blood leakage from the sheath.The physician stopped the blood leak, using his hand, and subsequently removed and exchanged the sheath.The new sheath was used to continue the procedure, involving treatment of a lesion below-the-knee.Per the user, "not too much" blood was lost; therefore, the patient did not require any treatment for blood loss.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: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The used complaint device was returned to cook for investigation.The hub was separated from the sheath, with no sheath material remaining in the hub.No damage was noted to the sheath flare.A bend was noted in the sheath; however, this was not reported by the customer and therefore likely occurred during shipping/handling of the device during return.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu warns "if resistance is encountered during sheath advancement, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this event.The risk analysis for this failure mode was reviewed and no additional 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.

• 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 ; 8123392235
• MDR Report Key: 17470840
• Report Number: 1820334-2023-01039
• Device Sequence Number: 15226512
• Product Code: DYB
• UDI-Device Identifier: 00827002299856
• UDI-Public: (01)00827002299856(17)260320(10)15283313
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 03/20/2026
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 15283313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK PTA5-35-135-5-10, TERUMO 35 WIRE.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 58 KG