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

Model Number	G29981
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: css logistics specialist.H3: device evaluation anticipated but not yet begun.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 angiogram of the left leg via access in the right groin, the hub of a flexor ansel guiding sheath separated from the shaft.The patient was heparinized during the procedure.Additional information has been requested but is unavailable at this time.
Additional Manufacturer Narrative
Additional information: b5, d9, e4, h3: device evaluated by mfg - device evaluation has begun; however, a conclusion is not yet available.Correction: h6 (annex e, f, a, and g).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
Additional information was received 19mar2026.The device separated during removal.A dilator was not re-inserted into the sheath prior to removal; an unspecified catheter was inside the sheath at the time while the user withdrew the sheath over the catheter in order to deploy an unspecified balloon/stent.The hub of the sheath along with the shaft of the sheath were used to pull the device from the patient.The catheter and wire guides were exchanged.The access site was scarred from a prior femoral bypass procedure but not diseased.The bifurcation was acute and calcified.Resistance was encountered during insertion and or advancement of the sheath along with resistance during removal of the device.Resistance was not encountered during the insertion/advancement of any device through the sheath.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Upon return of the device to cook, the sheath shaft was separated within the strain relief.

• 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: 24380663
• Report Number: 1820334-2026-00182
• Device Sequence Number: 10185695
• Product Code: DYB
• UDI-Device Identifier: 00827002299818
• UDI-Public: (01)00827002299818(17)280626(10)16662734
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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 Model Number: G29981
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 16662734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 05/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/09/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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 Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG