MAUDE Adverse Event Report: COOK INC BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G08447
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an unknown procedure, an unspecified cook "c2" catheter separated in the patient.Additional information has been requested.
Additional Manufacturer Narrative
E1: (b)(6).G4: 510(k) = k161822 or k173289.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional/corrected information: b1, b2, b3, b5, b7, d1, d4, e4, g4, h1, h4, 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.
Event or Problem Description
Additional information was received 24nov2025 and inadvertently omitted from the initial mdr.The beacon tip torcon nb advantage angiographic catheter was used during a fenestrated endovascular aneurysm repair procedure.Part of the device reportedly remains in the patient, who was hospitalized.The event resulted in prolonged exposure to x-ray and longer procedure time.According to the reporter, the patient did not experience any adverse effects due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, a beacon tip torcon nb advantage angiographic catheter separated during a fenestrated endovascular aneurysm repair procedure.Part of the device reportedly remains in the patient, who was hospitalized.The event resulted in prolonged exposure to x-ray and longer procedure time.According to the reporter, the patient did not experience any adverse effects due to this event.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 catheter was separated at the bond between the black tip and blue shaft.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no relevant discrepancies or additional relevant complaints on the final or sub-assembly lots.The product ifu states ¿if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿ 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.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to design or manufacturing, 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.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 23658941
• Report Number: 1820334-2025-01476
• Device Sequence Number: 13275707
• Product Code: DQO
• UDI-Device Identifier: 00827002084476
• UDI-Public: (01)00827002084476(17)260730(10)16182389
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173289
• 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,Followup
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2026
• Device Model Number: G08447
• Device Catalogue Number: HNBR5.0-38-65-P-NS-C2
• Device Lot Number: 16182389
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 02/24/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/05/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown