BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
Report
- Report Number
- 1820334-2025-01476
- Event Type
- Injury
- Date Received
- November 26, 2025
- Date of Event
- November 17, 2025
- Report Date
- February 24, 2026
- Manufacturer
- COOK INC
- Product Code
- DQO
- UDI-DI
- 00827002084476
- PMA / PMN Number
- K173289
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
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.
AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED COOK "C2" CATHETER SEPARATED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433097 | BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | COOK INC | G08447 | 16182389 | 00827002084476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |