COPE MANDRIL WIRE GUIDE
Report
- Report Number
- 1820334-2021-02025
- Event Type
- Injury
- Date Received
- August 19, 2021
- Report Date
- December 10, 2021
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002051836
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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. 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.
INVESTIGATION ¿ EVALUATION: (B)(6) UNIVERSITY CAMPUS (CANADA) INFORMED COOK ON (B)(6) 2021 OF AN INCIDENT INVOLVING A COPE MANDRIL WIRE GUIDE (RPN: PMG-18SP-60-COPE) FROM LOT 14024720. WHILE PERFORMING A PERMCATH INSERTION THE TIP OF THE WIRE BROKE OFF INTO THE PATIENT¿S RIGHT SUBCLAVIAN VEIN. THE PHYSICIAN HAD TO PERFORM A FOREIGN BODY RETRIEVAL BY PUNCTURING ANOTHER SITE TO RETRIEVE THE TIP. NO OTHER ADVERSE EFFECTS WERE REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD. DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE HISTORY RECORD (DHR) FOR LOT 14024720 AND PLATINUM COIL SUBASSEMBLY LOT (SA13847793) REVEALED NO RELEVANT REPORTED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE DEVICE LOT OR ANY OTHER LOT THE SUBASSEMBLY WAS USED IN. THE DEVICE¿S DESIGN HISTORY FILES (DHF) WERE REVIEWED, AND THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. CURRENT RISK CONTROLS INCLUDE DEVICES BEING WELDED WITH A ATRAUMATIC FINISH AND THE SURFACE CHARACTERISTICS ARE 100% INSPECTED AND VERIFIED PRIOR TO PACKAGING. COOK ALSO REVIEWED THE DEVICE INSTRUCTIONS FOR USE (IFU). THE PRODUCT IFU PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED 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. ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, DHF, IFU, AND DFA, SUGGEST THAT THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, OR THAT THERE ARE NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 OR UNAVAILABLE. 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.
IN ADDITIONAL INFORMATION PROVIDED 27SEP2021 IT WAS REPORTED THAT THE WIRE GUIDE WAS BENT PRIOR TO USE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 13AUG2021, IT WAS REPORTED THAT THE WIRE WAS NOT PULLED THROUGH A NEEDLE. THERE WAS NO RESISTANCE FELT WHEN PULLING OUT THE WIRE.
INITIAL REPORTER CUSTOMER (PERSON): POSTAL CODE (B)(6). INITIAL REPORTER OCCUPATION: COORDINATOR. 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.
IT WAS REPORTED THAT DURING A PERMACATH INSERTION, THE TIP OF THE COPE MANDRIL WIRE GUIDE BROKE OFF INTO THE RIGHT SUBCLAVIAN VEIN OF AN UNKNOWN PATIENT. A FOREIGN BODY RETRIEVAL WAS PERFORMED TO SECURE THE TIP. AN ADDITIONAL PUNCTURE AT ANOTHER SITE WAS NEEDED TO RETRIEVE THE BROKEN PIECE OF WIRE GUIDE. NO HARM TO THE PATIENT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE. THE RETRIEVED TIP OF THE WIRE GUIDE IS NOT AVAILABLE FOR RETURN, AS IT WAS FINE AND WAS LOST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238672 | COPE MANDRIL WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | N/A | 14024720 | 00827002051836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |