SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
Report
- Report Number
- 1820334-2024-01009
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Report Date
- November 26, 2024
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002034600
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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, PRIOR TO USE DURING PREPARATION FOR TWO UNKNOWN PROCEDURES, "ROUGHNESS" WAS NOTED NEAR THE TIP OF TWO SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDES. THIS WAS NOTED WHEN THE USER WAS ATTEMPTING TO SHAPE THE WIRES BY HAND AND WITH THE PURPLE INTRODUCER INCLUDED WITH THE WIRES. THE DEVICES DID NOT MAKE PATIENT CONTACT, AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED, NOTING THAT THE MANDRIL PROTRUDED FROM THE WIRES. 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. THE COMPLAINT DEVICES WERE NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE DEVICE LOT. A REVIEW OF COMPLAINT HISTORY FOUND TWO ADDITIONAL RELEVANT COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT INSTRUCTIONS FOR USE (IFU) WARNS: ¿ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ 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, AND IFU 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 AN UNINTENDED USER ERROR CONTRIBUTED TO THIS INCIDENT. THE DEVICE IFU WARNS, ¿ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ SINCE THE USER WAS SHAPING THE WIRE USING THE WIRE GUIDE INSERTER, THAT COULD POTENTIALLY BREAK SOME OF THE WELD BALL OFF, MAKING IT APPEAR SMALLER AND FEEL ROUGH. 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.
ADDITIONAL INFORMATION WAS RECEIVED, NOTING THAT THE MANDRIL PROTRUDED FROM THE WIRES.
AS REPORTED, PRIOR TO USE DURING PREPARATION FOR TWO UNKNOWN PROCEDURES, "ROUGHNESS" WAS NOTED NEAR THE TIP OF TWO SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDES. THIS WAS NOTED WHEN THE USER WAS ATTEMPTING TO SHAPE THE WIRES BY HAND AND WITH THE PURPLE INTRODUCER INCLUDED WITH THE WIRES. THE DEVICES DID NOT MAKE PATIENT CONTACT, AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURES.
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 |
|---|---|---|---|---|---|---|---|
| 485224 | SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | G03460 | 15864766 | 00827002034600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |