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

Model Number	G13033
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: procurement services intern.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.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
As reported, during an unspecified procedure, the "valve" on a flexor guiding sheath broke and "got stuck" in the patient while attempting to remove a captured foreign body.Per the reporter, "no harm was caused".Additional information regarding the event was requested, however, it is currently unavailable.
Additional Manufacturer Narrative
Additional/corrected information: b5, d10, h6 (annex a & g) summary of event: as reported, during an unspecified procedure, the "valve" on a flexor guiding sheath broke and "got stuck" in the patient while attempting to remove a captured foreign body.Per the reporter, "no harm was caused." additional information regarding the event was requested, however, it is currently unavailable.Upon return of the device on 30sep2024, the sheath was separated into two sections, and the proximal end of the sheath protruded from the hub.Investigation evaluation: reviews of the complaint history, device history record (dhr), 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 complaint device was returned to cook for investigation.The sheath was separated.The distal section measured 13.8-centimeters in length and the proximal section was 64.3-centimeters in length.The inner coils were exposed at the points of separation.The sheath hub was broken and pushed down onto the shaft, with the proximal end of the sheath protruding through the check-flo hub.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on one device; however, the affected product was scrapped.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿all interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Although one relevant non-conformance was noted on the lot, the non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.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.It is possible that the sheath separation could have been caused by the blades on the other manufacturer¿s valvulotome during the procedure; however, this cannot be definitively determined.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
Upon return of the device on 30sep2024, the sheath was separated into two sections, and the proximal end of the sheath protruded from the hub.

• Brand Name: FLEXOR 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: 20238788
• Report Number: 1820334-2024-01231
• Device Sequence Number: 18183543
• Product Code: DYB
• UDI-Device Identifier: 00827002130333
• UDI-Public: (01)00827002130333(17)240106(10)13671331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 01/06/2024
• Device Model Number: G13033
• Device Catalogue Number: KCFW-10.0-38-80-RB
• Device Lot Number: 13671331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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: OTW LEMAITRE VALVULOTOME 1005-00 LOT ELV61088V
• Patient Sex: Unknown