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

Model Number	G56222
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone = (b)(6).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 by a distributor, prior to use for an endovascular aortic repair procedure, condensation was noted in a flexor high-flex ansel guiding sheath's package.Per the distributor, it appears as though something heavy was on the device or rolled over the device, as "marks on the box" aligned with the sheath damage.The distributor conducted an internal investigation and concluded that the damage was not attributed to the distributor's processes.Per the distributor, the flexor high-flex ansel guiding sheath is generally used with "v12 stents" in "high stress/risk/cost procedures"; however, the complaint device was not usable and therefore, the stents were not placed as intended.The patient will be monitored and may return for stent placement in the future.The patient did not require any additional procedures or experience any adverse effects due to this event.

• Brand Name: FLEXOR HIGH-FLEX 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: 24071000
• Report Number: 1820334-2026-00044
• Device Sequence Number: 21114701
• Product Code: DYB
• UDI-Device Identifier: 00827002562226
• UDI-Public: (01)00827002562226(17)280814(10)16742107
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: G56222
• Device Catalogue Number: KCFW-7.0-35-70-RB-HFANL0-HC
• Device Lot Number: 16742107
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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 Sex: Male