BENTSON STRAIGHT FIXED CORE WIRE GUIDE
Report
- Report Number
- 1820334-2024-01096
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Report Date
- September 10, 2024
- Manufacturer
- COOK INC
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
D9, H3: REPORTEDLY, ONE OF THE WIRES WILL BE RETURNED TO COOK. E3: OCCUPATION = LEAD TECH G4: PMA/510(K) NUMBER = K171764 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, DURING TWO SEPARATE PROCEDURES INVOLVING EMBOLIZATION OF THE LEFT UTERINE ARTERY VIA CONTRALATERAL ACCESS IN THE RIGHT FEMORAL ARTERY, TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES UNRAVELED UPON REMOVAL (ONE WIRE UNRAVELED IN EACH PROCEDURE). THE ANATOMY WAS "A BIT" TORTUOUS; HOWEVER, RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE WIRES. THE WIRES WERE NOT ALTERED PRIOR TO USE, AND THEY WERE NOT MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. ANOTHER MANUFACTURER'S SHEATH AND CATHETER WERE USED DURING THE PROCEDURES. REPORTEDLY, UPON REMOVAL OF THE WIRES, THE COILS "SEPARATED" FROM THE MANDRIL. THE PROCEDURES WERE SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENTS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS 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 WAS CONDUCTED AS WELL. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. EXAMINATION OF THE RETURNED DEVICE FOUND THAT MEASURING FROM THE DISTAL TIP, AN UNRAVELED AREA WAS NOTED AT APPROXIMATELY 14.5CM THAT EXTENDED FOR 1.1CM. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. DUE TO THE LACK OF A LOT NUMBER FROM THE USER FACILITY, A GLOBAL SHIPMENT SEARCH ON THE USER FACILITY AND COMPLAINT DEVICE WAS PERFORMED BUT COULD NOT DEFINITIVELY DETERMINE THE LOT NUMBER OF THE COMPLAINT DEVICE. AT THIS TIME, COOK COULD NOT CONCLUDE THAT NONCONFORMING PRODUCT FROM THE AFFECTED LOT EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED THE PRODUCT LABELING, INCLUDING THE INSTRUCTIONS FOR USE (IFU). THE CUSTOMER FOLLOWED ALL RELEVANT INSTRUCTIONS IN THE IFU RELATED TO THIS FAILURE. 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, RETURNED DEVICE, AND COMPLAINT FILE 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 COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. ALTHOUGH THE CUSTOMER NOTED THAT THE ANATOMY WAS A BIT TORTUOUS, NO RESISTANCE WAS FELT. THE EXACT CONDITIONS EXPERIENCED DURING THE EVENT CANNOT BE DUPLICATED. 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 TWO SEPARATE PROCEDURES INVOLVING EMBOLIZATION OF THE LEFT UTERINE ARTERY VIA CONTRALATERAL ACCESS IN THE RIGHT FEMORAL ARTERY, TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES UNRAVELED UPON REMOVAL (ONE WIRE UNRAVELED IN EACH PROCEDURE). THE ANATOMY WAS "A BIT" TORTUOUS; HOWEVER, RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE WIRES. THE WIRES WERE NOT ALTERED PRIOR TO USE, AND THEY WERE NOT MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. ANOTHER MANUFACTURER'S SHEATH AND CATHETER WERE USED DURING THE PROCEDURES. REPORTEDLY, UPON REMOVAL OF THE WIRES, THE COILS "SEPARATED" FROM THE MANDRIL. THE PROCEDURES WERE SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENTS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
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 |
|---|---|---|---|---|---|---|---|
| 1127690 | BENTSON STRAIGHT FIXED CORE WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | G01290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 5FR 11CM AVANTI SHEATH| CORDIS 5FR CONTRA CATHETER |