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

Model Number	G12836
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A5: taiwanese.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, the hubs of two flexor shuttle tibial guiding sheaths separated during a procedure involving an aortic dissection with false lumen.Access was obtained in the femoral artery.The access site and anatomy were reportedly ¿normal¿, and resistance was not encountered during insertion or advancement of the sheath.A cook coil was used through the sheath, as well as another manufacturer¿s wire guide and another manufacturer¿s vascular plug.Resistance was not encountered during insertion or advancement of any device through the sheath.Per the reporter, when the vascular plug was almost in place, the physician wanted to adjust the location, so the plug was pulled back, at which point the user noted that the sheath had separated from the hub.Resistance was encountered during sheath removal, and the hub was used to pull the sheath from the patient.The sheath was removed and exchanged for ¿another one¿, and the user reportedly tested the ¿new one¿ with ¿normal strength¿; however, the hub of that device also separated.The sheath was exchanged for a third device to complete the procedure.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 event.

• Brand Name: FLEXOR SHUTTLE TIBIAL 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: 24119498
• Report Number: 1820334-2026-00069
• Device Sequence Number: 15831613
• Product Code: DYB
• UDI-Device Identifier: 00827002128361
• UDI-Public: (01)00827002128361(17)280630(10)16673111
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• 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: G12836
• Device Catalogue Number: KSAW-8.0-38-90-RB-SHTL-HC
• Device Lot Number: 16673111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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: ABBOTT AMPLATZER VASC PLUG AVP II 16¿18.; COOK MWCE-35-14-14-NESTER.; TERUMO 0.035 WIRE.
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian