BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
Report
- Report Number
- 1820334-2019-02955
- Event Type
- Injury
- Date Received
- November 26, 2019
- Report Date
- April 2, 2020
- Manufacturer
- COOK INC
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
G5: PMA/510(K) NUMBER = K173289. 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, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY AS REPORTED, DURING AN UNKNOWN PROCEDURE IN WHICH AN UNSPECIFIED COOK BEACON TIP CATHETER WAS USED, THE HEPATIC ARTERY DISSECTED. THE USER REPORTEDLY APPLIED ADDITIONAL TORQUE ON THE CATHETER DUE TO THE RIGIDITY OF THE TIP. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE DEVICE REPORTED. INVESTIGATION - EVALUATION REVIEWS OF THE DOCUMENTATION, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, SPECIFICATIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE THUS PROVIDES EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE DEVICE IS PACKAGED WITH INSTRUCTIONS FOR USE, WHICH STATE THAT BEACON TIP CATHETERS ARE INTENDED FOR USE IN ANGIOGRAPHIC PROCEDURES BY PHYSICIANS TRAINED AND EXPERIENCED IN ANGIOGRAPHIC TECHNIQUES. THE IFU PRECAUTIONS, ¿MANIPULATION OF THE CATHETER REQUIRES FLUOROSCOPIC CONTROL¿ AND, ¿IF RESISTANCE IS ENCOUNTERED DURING MANIPULATION, STOP AND DETERMINE THE CAUSE BEFORE PROCEEDING ANY FURTHER.¿ THE IFU ALSO INSTRUCTS, ¿UNDER FLUOROSCOPIC GUIDANCE, ADVANCE THE CATHETER OVER AN APPROPRIATELY SIZED WIRE GUIDE OR THROUGH AN APPROPRIATELY SIZED SHEATH INTRODUCER TO THE INTENDED LOCATION.¿ ADDITIONALLY, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, SPECIFICATIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON A REVIEW OF THE COMPLAINT AND WHAT THE CUSTOMER REPORTED, THERE IS NO ALLEGED DEVICE MALFUNCTION. THE CUSTOMER REPORTED THAT THEY BELIEVE THAT THE DISSECTION WAS DUE TO THE RIGIDITY OF AND THE TORQUE APPLIED TO THE DEVICE. COOK HAS CONCLUDED THAT USER TECHNIQUE CONTRIBUTED TO THIS INCIDENT. THE IFU PRECAUTIONS STATE, ¿IF RESISTANCE IS ENCOUNTERED DURING MANIPULATION, STOP AND DETERMINE THE CAUSE BEFORE PROCEEDING ANY FURTHER.¿ WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PER THE INITIAL REPORTER, IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING AN UNKNOWN PROCEDURE IN WHICH AN UNSPECIFIED COOK BEACON TIP CATHETER WAS USED, THE HEPATIC ARTERY DISSECTED. THE USER REPORTEDLY APPLIED ADDITIONAL TORQUE ON THE CATHETER DUE TO THE RIGIDITY OF THE TIP. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE DEVICE REPORTED. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1169252 | BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |