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

Catalog Number	KCFW-5.5-38-40-RB-BLKN
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2023
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 an unknown procedure, two flexor balkin guiding sheaths unraveled upon removal of the devices from the patient.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, two flexor balkin guiding sheaths unraveled upon removal of the devices from the patient.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint devices was also conducted.The complaint devices were returned to cook for investigation.Both used sheaths were unraveled and heavily damaged, with bends and kinks along both shafts.A dilator was lodged in one of the sheaths.There was no damage noted to three unused devices also returned to cook from the customer.A document-based investigation evaluation was performed.No related non-conformances or additional complaints were found on the final lot or raw material lots.The product ifu states ¿if resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned devices suggests that there is evidence the devices were 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 limited information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, 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.
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 BALKIN 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: 17443332
• Report Number: 1820334-2023-01004
• Device Sequence Number: 11441032
• Product Code: DYB
• UDI-Device Identifier: 00827002126565
• UDI-Public: (01)00827002126565(17)251205(10)15108803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 12/05/2025
• Device Catalogue Number: KCFW-5.5-38-40-RB-BLKN
• Device Lot Number: 15108803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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