LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
Report
- Report Number
- 3002808486-2022-00048
- Event Type
- Malfunction
- Date Received
- February 1, 2022
- Date of Event
- December 8, 2021
- Report Date
- April 5, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DQX
- UDI-DI
- 00827002314535
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER REF# (B)(4). OCCUPATION: UNKNOWN. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171513. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE TIP OF THE WIRE GUIDE FELL OFF AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. AN INVESTIGATION OF THE RETURNED STRAIGHT WIRE GUIDE REVEALED AN ELONGATION STARTING 70MM FROM THE MOST DISTAL TIP. THE INNER MANDRIL HAD FRACTURED CLOSE TO THE TIP WELDING AND PROTRUDED THE ELONGATION. HOWEVER, THE MOST DISTAL PART OF THE MANDRIL WAS STILL ATTACHED TO THE WELDING, THUS SUGGESTING THAT THE WELDING HAD BEEN ACCORDING TO SPECIFICATIONS AND FIXED THE COMPONENTS DISTALLY AS INTENDED. BASED ON THESE INVESTIGATION FINDINGS THE EXACT REASON FOR THE DAMAGED WIRE GUIDE CANNOT BE DETERMINED. HOWEVER, AS THE WIRE GUIDE APPEARED CLEAN AND AS THE TIP OF THE INNER MANDRIL WAS CURVED, IT IS SUGGESTED THAT THE WIRE GUIDE WAS SOMEHOW DAMAGED DURING ATTEMPTS TO ALTER THE WIRE GUIDE TIP PRIOR TO USE, BUT THIS IS ONLY SPECULATION BASED ON THE VERY LIMITED INFORMATION PROVIDED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURER REF# (B)(4). OCCUPATION: UNKNOWN. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171513. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE END TIP OF THE WIRE GUIDE FALL OFF, THEN A NEW WIRE GUIDE WAS REPLACED AND COMPLETED THE PROCEDURE SUCCESSFULLY. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT 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.
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE END TIP OF THE WIRE GUIDE FALL OFF, THEN A NEW WIRE GUIDE WAS REPLACED AND COMPLETED THE PROCEDURE SUCCESSFULLY. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1213117 | LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | WILLIAM COOK EUROPE | G31453 | E4156069 | 00827002314535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |