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

Model Number	G08581
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unspecified neurological procedure, a beacon tip torcon nb advantage angiographic catheter's hub separated.Access was obtained via the femoral artery targeting the internal carotid artery.The hub was not wiped down with any cleaning solution.Another manufacturer's power injector was used and the catheter's hub "blew off" at 1000 psi.The catheter was removed under fluoroscopy intact, and another same type of device was used to complete the procedure successfully.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 the occurrence.
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.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
Summary of event: as reported, during an unspecified neurological procedure, a beacon tip torcon nb advantage angiographic catheter's hub separated.Access was obtained via the femoral artery targeting the internal carotid artery.The hub was not wiped down with any cleaning solution.Another manufacturer's power injector was used and the catheter's hub "blew off" at 1000 psi.The catheter was removed under fluoroscopy intact, and another same type of device was used to complete the procedure successfully.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 the occurrence.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 hub was separated from the catheter.Glue residue was present on the catheter, and no catheter material was left in the hub.A document-based investigation evaluation was performed.A review of the device history record found no non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The customer followed relevant instructions in the ifu (instructions for use).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.

• 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: 20877528
• Report Number: 1820334-2024-01613
• Device Sequence Number: 8843428
• Product Code: DQO
• UDI-Device Identifier: 00827002085817
• UDI-Public: (01)00827002085817(17)251102(10)15739896
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K173289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 11/02/2025
• Device Model Number: G08581
• Device Catalogue Number: HNBR5.0-38-100-P-NS-DAV
• Device Lot Number: 15739896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDRAD MARK 7, NAMIC BRAIDED TUBING
• Patient Sex: Unknown