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

Model Number	G13792
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone: (b)(6).H3 - device evaluated by mfg?: device evaluation is anticipated but has 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 or that a death or serious injury occurred; nor is it admission 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
It was reported that the tip of a torcon nb advantage van schie beacon tip seeking catheter separated.The device was required for a fenestrated endovascular aneurysm repair (evar) procedure.The graft with fenestrations for the celiac artery, superior mesenteric artery (sma), and right renal artery (rra) was deployed.The cook beacon tip catheter was advanced over a glide wire into the sma and graft fenestration.The glide wire was removed, a contrast run was performed, then a 260cm cook rosen wire was advanced through the catheter.Upon removal of the catheter, the catheter separated, leaving the gray tip inside the patient's main sma trunk.Various attempts to remove the tip, including snaring and alligator forceps, were unsuccessful.After 60-70 minutes, it was determined the tip could not be retrieved from the patient.As a result, a bare-metal, self-expanding stent was deployed adjacent to the graft to "cage" the catheter tip between the stent and sma wall.No other adverse effects were reported for this incident.
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
Investigation ¿ evaluation: as reported, the tip of a torcon nb advantage van schie beacon tip seeking catheter separated during a fenestrated endovascular aneurysm repair (evar) procedure.The graft with fenestrations for the celiac artery, superior mesenteric artery (sma), and right renal artery (rra) were deployed.The cook beacon tip catheter was advanced over a glide wire into the sma and graft fenestration.The glide wire was removed, a contrast run was performed, then a 260 cm cook rosen wire was advanced through the catheter.Upon removal of the catheter, the catheter separated, leaving the gray tip inside the patient's main sma trunk.Various attempts to remove the tip, including snaring and alligator forceps, were unsuccessful.After 60-70 minutes, it was determined the tip could not be retrieved from the patient.As a result, a bare-metal, self-expanding stent was deployed adjacent to the graft to "cage" the catheter tip between the stent and sma wall.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.The complainant returned one used device to cook for investigation.Physical examination of the returned device found that the tapered tip was missing.The tip was cleanly broken from the catheter material.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported lot and related subassembly lots records a relevant non-conformance; however, all non-conforming product was scrapped prior to release, and there are 100% inspections in place to capture this non-conformance.A database search for complaints on the reported lot found two additional complaints from the field for the same failure mode as the complaint device.These complaints both concluded manufacturing as the cause of failure.Additional final lots manufactured by the relevant operator were reviewed.Another complaint was found with the same failure mode from a different lot.Cook also reviewed product labeling.The ifu for the device, t_hnb_rev2, cautions that if resistance is encountered during manipulation, to stop and determine the cause before proceeding any further.The ifu also cautions not to attempt to heat or re-shape the catheter curve.The ifu instructs "under fluoroscopic guidance, advance the catheter over an appropriately sized wire guide or through an appropriately sized sheath introducer to the intended location." the information provided upon review of the dhr and investigation of the returned device suggests that there is evidence the device was manufactured out of specification, and that there are additional nonconforming devices in the field.A containment and recall were initiated on affected lots.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded manufacturing deficiency contributed to this incident.It is unknown if resistance was encountered during insertion, advancement, or removal of the catheter, and unknown if the user attempted to re-shape the curve of the catheter.It is possible that the catheter may have caught within the fenestration/graft; however, this cannot be definitively determined based on current information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures have been initiated to address this failure mode.A nonconformance investigation (nc) is currently ongoing to further investigate this issue.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: TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING 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: 21752879
• Report Number: 1820334-2025-00319
• Device Sequence Number: 8087321
• Product Code: DQO
• UDI-Device Identifier: 00827002137929
• UDI-Public: (01)00827002137929(17)260319(10)15953576
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173289
• Number of Events Summarized: 1
• Summary Report (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): 07/14/2025

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: 03/19/2026
• Device Model Number: G13792
• Device Catalogue Number: HNBR5.0-35-65-P-NS-VANSCHIE3
• Device Lot Number: 15953576
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALLIGATOR FORCEPS; BARE METAL SELF-EXPANDING STENT; COOK ROSEN WIRE 260 CM; SNARE
• Patient Age: 86 YR
• Patient Sex: Male