COOK COPE-LOOP CATHETER
Report
- Report Number
- 1820334-2021-02038
- Event Type
- Injury
- Date Received
- August 23, 2021
- Report Date
- December 10, 2021
- Manufacturer
- COOK INC
- Product Code
- LJE
- UDI-DI
- 00827002142831
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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.
DESCRIPTION OF EVENT: IT WAS REPORTED THAT DURING A NEPHROSTOMY MALFUNCTION REPLACEMENT PROCEDURE, THE TETHER OF THE COOK COPE-LOOP CATHETER BECAME STUCK IN THE PATIENT. FORCE WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT. THE TETHER WAS CUT IN ORDER TO RETRIEVE THE DEVICE, AND A SEGMENT OF THE TETHER REMAINED IN THE PATIENT. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ¿THE CUT CATHETER RETURNED TO COOK FOR INVESTIGATION. THE PRESENCE OF BIO OR FOREIGN MATTER NOTED ON SURFACE OF CATHETER. AN INSPECTION OF THE CUT CATHETER END SHOWED THAT THE STRAIGHTENER AND WIRE GUIDE WERE STILL PRESENT INSIDE THE CATHETER SEGMENT. THEY DON'T APPEAR TO GO ALL THE WAY TO THE END OF THE CATHETER THOUGH AS THEY ARE NOT VISIBLE THROUGH THE SIDEPORT HOLES ALONG THE CATHETERS END CURL. 31.75 CM OF GREEN TETHER REMAINS ATTACHED TO THE CATHETER AT TAPERED TIP. BLACKISH/BROWNISH STRING IS WRAPPED AROUND THE CENTER OF THE RETURNED CATHETER SEGMENT AND APPEARS TO BE TANGLED AND WRAPPED WITH TAPE OR SOMETHING SIMILARLY ADHESIVE. THE BLACKISH/BROWNISH STRING DOES NOT APPEAR TO BE DISCOLORED GREEN TETHER AS THE BLACK/BROWN STRING IS OF A LARGER DIAMETER.¿ A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿PRECAUTIONS DO NOT FORCEFULLY ADVANCE ANY COMPONENTS DURING REMOVAL OR REPLACEMENT OF THE CATHETER. CAREFULLY REMOVE THE COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED.¿ ¿INSTRUCTIONS FOR USE CATHETER PLACEMENT IMPORTANT: TO AVOID BREAKING THE CATHETER TETHER, UNWIND SEVERAL CENTIMETERS OF TETHER FROM THE ATTACHED SPOOL AND GENTLY STRAIGHTEN THE CATHETER LOOP.¿GRADUALLY ADVANCE THE CATHETER IN THE COLLECTING SYSTEM.¿ ¿IF IT BECOMES DIFFICULT TO ADVANCE THE CATHETER, INSERT THE CATHETER INTRODUCTION STIFFENING CANNULA OVER THE WIRE GUIDE AND INTO THE CATHETER. SOME LUBRICANT MAY BE HELPFUL CATHETER REMOVAL GENTLY WITHDRAW THE CATHETER. THE SOFT, RETENTIVE COIL WILL STRAIGHTEN DURING REMOVAL¿ A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. A ROOT CAUSE FOR THE INCIDENT COULD NOT BE DETERMINED GIVEN THE LIMITED AVAILABLE INFORMATION REGARDING THE INCIDENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.
ADDITIONAL INFORMATION WAS RECEIVED 22OCT2021. FORCE WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT. THE TETHER WAS CUT IN ORDER TO RETRIEVE THE DEVICE, AND A SEGMENT OF THE TETHER REMAINED IN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
COMMON NAME & PRODUCT CODE- SUBSEQUENT PRODUCT CODE: KOB- CATHETER, SUPRAPUBIC (AND ACCESSORIES). PMA/510(K) NUMBER = K191498. 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 NEPHROSTOMY MALFUNCTION REPLACEMENT PROCEDURE, THE TETHER OF THE COOK COPE-LOOP CATHETER BECAME STUCK IN THE PATIENT. IT IS UNKNOWN HOW OR IF THE TETHER WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1249969 | COOK COPE-LOOP CATHETER | LJE CATHETER, NEPHROSTOMY | LJE | COOK INC | G14283 | 13725147 | 00827002142831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |