MAUDE Adverse Event Report: COOK INC TRIFORCE¿ PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number	KCXS-5.0-35-100-RB-0/0-HC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
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 = other (81) - 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.
Event or Problem Description
As reported, during a transjugular intrahepatic portosystemic shunt (tips) recanalization procedure, approximately six inches of a triforce peripheral crossing set's catheter separated.The access site was not scarred, and the anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered during insertion or removal of the device.Another device was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, the catheter was separated.The sheath was also damaged at the hub and near the tip.
Additional Manufacturer Narrative
Summary of event: as reported, during a transjugular intrahepatic portosystemic shunt (tips) recanalization procedure, approximately six inches of a triforce peripheral crossing set's catheter separated.The access site was not scarred, and the anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered during insertion or removal of the device.Another device was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, the catheter was separated.The sheath was also damaged at the hub and near the tip.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also performed.The complaint device was returned to cook for investigation.The catheter shaft was separated at 16 cm from the distal tip, and the proximal part of the shaft to the hub measured 84.6 cm.Damage was noted at the distal tip, the second marker band from the tip, and on the shaft 2.7 cm from the tip.The flexor had damage near the hub and at 0.08 cm from the distal tip.A document-based investigation evaluation was performed.No related non-conformances or additional complaints were found on the final lot.The catheter subassembly lot records 2 relevant nonconformances on 3 total devices with shaft damage.However, all nonconforming products were scrapped, and the lot is inspected 100%.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, returned complaint device, and complaint file suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Although two relevant non-conformances were noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to the design or manufacturing, caused this incident.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TRIFORCE¿ PERIPHERAL CROSSING SET
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• 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: 18512665
• Report Number: 1820334-2024-00073
• Device Sequence Number: 3666568
• Product Code: KRA
• UDI-Device Identifier: 00827002564169
• UDI-Public: (01)00827002564169(17)260920(10)15435580
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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 Expiration Date: 09/20/2026
• Device Catalogue Number: KCXS-5.0-35-100-RB-0/0-HC
• Device Lot Number: 15435580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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 Age: 74 YR
• Patient Sex: Female