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

Model Number	G13081
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the internal wire of a flexor rtps guiding sheath unraveled during use, which prevented continuation of the transjugular intrahepatic portosystemic shunt (tips) procedure.Multiple stents were lost as a result, and the procedure had to be restarted after removal of the affected access sheath.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3 - device evaluated by mfg? it is unknown if the device will be returned to the manufacturer 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, d9 - device available for evaluation, d10, e4 - initial report sent to fda correction: h3 h3 - device evaluated by mfg?: device evaluation anticipated but has not yet begun.Awaiting device return.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 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
In additional information provided on 14jan2026, it was reported that there was difficulty removing the dilator from the sheath.The wire that was inside the sheath unraveled, preventing the case from moving forward.The patient was not hospitalized due to this occurrence.

• Brand Name: FLEXOR RTPS 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: 23864839
• Report Number: 1820334-2025-01589
• Device Sequence Number: 4551959
• Product Code: DYB
• UDI-Device Identifier: 00827002130814
• UDI-Public: (01)00827002130814(17)281008(10)16816446
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/21/2026

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: G13081
• Device Catalogue Number: KCFW-10.0-35-RB-RTPS-100
• Device Lot Number: 16816446
• Was Device Available for Evaluation?: Yes
• 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: 01/14/2026; 05/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/21/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: COOK: RTPS-100-10.0, LOT#: UNKNOWN.; COOK: RUPS-100, LOT#: UNKNOWN.
• Patient Sex: Unknown