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

Model Number	G56236
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg - device evaluation has begun; however, a conclusion is not yet available.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 a procedure involving angioplasty, a flexor high-flex ansel guiding sheath's shaft unraveled.Access was obtained via the common femoral artery to target the calcified mid superficial femoral artery (sfa).Another manufacturer's catheter was used during the procedure.Upon removal from the patient, resistance was encountered and the complaint device "caught on some calcium" and unraveled.The dilator was not in place when the device unraveled.The user did not have trouble removing the device from the patient manually.The procedure had successfully been completed with the complaint device.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.

• 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: 24393153
• Report Number: 1820334-2026-00198
• Device Sequence Number: 13326390
• Product Code: DYB
• UDI-Device Identifier: 00827002562363
• UDI-Public: (01)00827002562363(17)280611(10)16638977
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: G56236
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL1-HC
• Device Lot Number: 16638977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BARD SEEKER CATHETER
• Patient Sex: Unknown