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

Model Number	G56416
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 an unknown procedure, a triforce peripheral crossing set's sheath broke at the hub.Reportedly, the user does not believe that the device was subjected to excessive force or angulation.A photo provided by the customer appears to show that the sheath is unraveled below the hub.Additional information has been requested.
Event or Problem Description
Additional information was received 13nov2024 and inadvertently omitted from the initial report.The break/unraveling was noted after successful use and removal of the device, per the instructions for use.The procedure was completed successfully, without incident.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.No additional information will be provided.
Additional Manufacturer Narrative
Additional/corrected information: b3, b5, h6 (annexes e & f).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
Summary of event: as reported, during an unknown procedure, a triforce peripheral crossing set's sheath broke at the hub.Reportedly, the user does not believe that the device was subjected to excessive force or angulation.A photo provided by the customer appears to show that the sheath is unraveled below the hub.The break/unraveling was noted after successful use and removal of the device, per the instructions for use.The procedure was completed successfully, without incident.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.No additional information will be provided.G1: contact office country: united states g1: manufacturing site country: united states 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 complaint device was also conducted.The complaint device was returned to cook for investigation.The sheath material had begun to separate just below the hub, exposing the inner coil and liner; however, the sheath was not fully separated.The sheath was also kinked approximately 37-centimeters and 75.5-centimeters from the hub.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final or sub-assembly lots.A review of complaint history found no additional relevant complaints for the final or sub-assembly lots.The product ifu states ¿the device should not be forced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ 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, and investigation of the returned device 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.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.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: 20682832
• Report Number: 1820334-2024-01484
• Device Sequence Number: 7234727
• Product Code: KRA
• UDI-Device Identifier: 00827002564169
• UDI-Public: (01)00827002564169(17)270913(10)16235986
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

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 Model Number: G56416
• Device Catalogue Number: KCXS-5.0-35-100-RB-0/0-HC
• Device Lot Number: 16235986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 01/14/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/20/2024; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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 Sex: Unknown