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

Model Number	G11636
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, a flexor raabe guiding sheath "snapped" and unraveled upon removal of the device.The patient did not experience any adverse effects due to this event.Additional information has been requested but is not available at this time.
Additional Manufacturer Narrative
E3: supply chain specialist h3: 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 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.
Additional Manufacturer Narrative
Additional information: b5, d10.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 01apr2026.The intended procedure was a drug-coated balloon (dcb) intervention for an occluded superficial femoral artery (sfa).Femoral access was used, with the access site presenting as normal in condition.A contralateral approach was taken for the procedure.The anatomy encountered was stenosed with heavy calcium present, though no chronic total occlusion (cto) was identified.Another manufacturer¿s catheter was used through the sheath during the procedure.Resistance during insertion and advancement of the sheath was not unusual.However, resistance was encountered during removal of the sheath, and it was at this point that the sheath came apart.No resistance was noted during the insertion or advancement of devices through the sheath.The dilator was not reinserted prior to sheath removal.The procedure was completed successfully.Although the sheath separated during removal, it did not fully come apart, and no retrieval procedure was required.The sheath was removed in its entirety with time and caution applied to the remainder of the removal process.No unintended section of the device was left inside the patient's body, and no additional procedures were required as a result of this event.

• Brand Name: FLEXOR RAABE 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: 24305992
• Report Number: 1820334-2026-00157
• Device Sequence Number: 5215131
• Product Code: DYB
• UDI-Device Identifier: 00827002116368
• UDI-Public: (01)00827002116368(17)281023(10)16839675
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/05/2026

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: G11636
• Device Catalogue Number: KCFW-6.0-38-70-RB-RAABE
• Device Lot Number: 16839675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/01/2026; 05/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/09/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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: DCB - MEDTRONIC IN.PACT.
• Patient Sex: Unknown