COPE MANDRIL WIRE GUIDE
Report
- Report Number
- 1820334-2023-01479
- Event Type
- Malfunction
- Date Received
- October 30, 2023
- Report Date
- August 6, 2024
- Manufacturer
- COOK INC
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3 - OCCUPATION: INSIDE SALES. G4 - PMA/510(K) #: K171997 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. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: H6 - ANNEX A. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT A COPE MANDRIL WIRE GUIDE UNRAVELED. THE USER NOTED THAT NOTHING ABNORMAL WAS DONE DURING THE PROCEDURE; HOWEVER, WHEN THE WIRE GUIDE WAS REMOVED AFTER ACCESS WAS OBTAINED, THE WELD AT THE END OF THE WIRE FAILED AND THE WIRE BEGAN TO UNRAVEL. THE WIRE WAS ABLE TO BE REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU) OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU, T_MWG_REV0, PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "WARNINGS: THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. AVOID MANIPULATING OR WITHDRAWING THE WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE OR SHEAR MATERIAL FROM THE WIRE GUIDE. INSTRUCTIONS FOR USE: 1.) FLUSH THE WIRE GUIDE HOLDER BY ATTACHING A SYRINGE WITH HEPARINIZED SALINE OR STERILE WATER TO THE FITTING OF THE WIRE GUIDE HOLDER. INJECT ENOUGH SOLUTION TO WET THE WIRE SURFACE ENTIRELY. NOTE: IF FLUSHING THROUGH THE WIRE GUIDE HOLDER IS NOT POSSIBLE, REMOVE THE WIRE GUIDE FROM THE HOLDER AND PLACE IT IN A BOWL OF HEPARINIZED SALINE OR STERILE WATER, OR WET THE WIRE GUIDE SURFACE OVER THE ENTIRE LENGTH USING GAUZE THAT HAS BEEN MOISTENED WITH HEPARINIZED SALINE SOLUTION. 2.) CAREFULLY REMOVE THE WIRE GUIDE FROM THE HOLDER. 3.) IF NEEDED, INSERT A WIRE GUIDE INSERTION TOOL (PROVIDED) THROUGH THE VALVE ASSEMBLY OR HUB OF THE GUIDING SHEATH OR OTHER INTERVENTIONAL DEVICE. INSERT THE TIP OF THE WIRE GUIDE THROUGH THE INSERTION TOOL AND ADVANCE THE WIRE GUIDE TO THE DESIRED LOCATION. 4.) ATTACH A TORQUE DEVICE TO THE WIRE GUIDE (IF PROVIDED). 5.) STANDARD WIRE GUIDE TECHNIQUES MAY NOW BE EMPLOYED. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE DMR, IFU, NO DHR AND NO PRODUCT RETURN, COOK WAS NOT ABLE TO FIND EVIDENCE THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO FIND EVIDENCE OF NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK WAS NOT ABLE TO DETERMINE A CAUSE FOR THIS EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
B3 - DATE OF EVENT: IT IS POSSIBLE THAT THE DATE OF EVENT WAS 16OCT2023. 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. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. 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.
IT WAS REPORTED THAT A COPE MANDRIL WIRE GUIDE UNRAVELED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN PATIENT. THE USER NOTED THAT NOTHING ABNORMAL WAS DONE DURING THE PROCEDURE; HOWEVER, WHEN THE WIRE GUIDE WAS REMOVED AFTER ACCESS WAS OBTAINED, THE WELD AT THE END OF THE WIRE FAILED AND THE WIRE BEGAN TO UNRAVEL. THE WIRE WAS ABLE TO BE REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 25JAN2024, IT WAS REPORTED THAT THE LOT NUMBER IS NOT AVAILABLE. IT WAS CONFIRMED THAT THE DEVICE IS NOT BEING RETURNED. THE PHYSICIAN NOTED THAT THEY DID NOTHING DIFFERENT THAN USUAL DURING THE PROCEDURE. THE WIRE WAS GOING TOWARD THE SUBCLAVIAN, AND AS THE PHYSICIAN PULLED THE WIRE BACK, IT STARTED TO COME APART. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH A NEW MICROPUNCTURE KIT, WITH A DIFFERENT WIRE.
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 |
|---|---|---|---|---|---|---|---|
| 2009479 | COPE MANDRIL WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | G05183 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |