COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE
Report
- Report Number
- 1923569-2017-00052
- Event Type
- Malfunction
- Date Received
- August 29, 2017
- Date of Event
- August 14, 2017
- Report Date
- October 24, 2017
- Manufacturer
- CAREFUSION, INC
- Product Code
- DXC
- PMA / PMN Number
- K991589
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
(B)(4): SEPTEMBER 2001. ONE (1) CV1161 COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE WAS RETURNED AS THE COMPLAINT SAMPLE. THE ETCHINGS ON THE SAMPLE WERE NOTED TO BE LEGIBLE, YET OBSCURED BLEMISHES: THE LOT CODE WAS DISPLAYED AS I01 ((B)(6) 2001), THE SAMPLE WAS ESTIMATED TO HAVE BEEN IN USE FOR MORE THAN 16 YEARS. THE SAMPLE DISPLAYED A USED APPEARANCE WITH SIGNS OF USAGE MARKS LIKE SCRATCHES, NICKS, DINGS, MARRING AND SURFACE SCUFF MARKS WERE NOTED ALL OVER AND PARTICULARLY TOWARDS THE WORKING END OF THE SAMPLE AND THE HANDLE HOLDING END. NO SIGNS OF REPAIR WORK, MODIFICATIONS AND/OR NON-PRINT OR NON-V. MUELLER MARKINGS WERE NOTED ON THE SAMPLE. IT WAS EVIDENT UPON INITIAL OBSERVATION, THE SAMPLE BODY WAS RETURNED BROKEN IN TWO PIECES AND THE BEAD COMPONENTS WERE SENT IN AS LOOSE PIECES. FURTHER INITIAL VISUAL INSPECTIONS REVEALED, 32 BEADS WERE COUNTED/RETURNED; CUSTOMER NOTED ALL THE BEADS WERE RETRIEVED. OTHER OBSERVATIONS REVEALED, THE METAL LUBRICATION TAG THAT IS NORMALLY ATTACHED TO THE FINGER RING HANDLE WAS MISSING AND NOT RETURNED, ONE OF THE MAIN BROKEN BODY PIECES WERE THE HANDLES AND HANDLE BODY AND THE OTHER MAIN BROKEN PIECE WAS THE CABLE WIRE (99-900-070) ATTACHED TO THE JAWS END. FOR TESTING PURPOSES, THE RATCHETING OF THE FINGER RING HANDLES WERE NOTED TO BE FUNCTIONING NORMALLY, AND THE JAWS AT THE WORKING END HAD NO TENSION DUE TO THE BROKEN OFF CABLE WIRE. THE SAMPLE WAS COMPLETELY NON-FUNCTIONAL AND NO OTHER FUNCTIONAL TESTS COULD BE PERFORMED. THE FAILURE MODE WAS OBSERVED AT THE JUNCTION WHERE THE (CLEVIS) EYE-FITTING (31-300-862) ENDS AND WHERE THE SWAGED/BRAZED FITTING ON THE CABLE BEGINS. THE BREAK APPEARED TO BE A SHEAR WITH A JAGGED BREAK OF THE CABLE WIRE THAT LEFT A BURR IN THE THREADED EYE FITTING. CLOSER INSPECTIONS REVEALED THE WOUND CABLE WIRE DID NOT UNRAVEL FROM THE HELICAL SHAPE. THE BREAK APPEARED TO BE A CRACK AT THE WELD/CRIMP POINT, NO CORROSION WAS NOTED ON THE ENTIRE LENGTH OF THE CABLE. IT SHOULD BE NOTED THAT 2001 MANUFACTURING PROCESSES INVOLVED BRAZING/WELDING THE WOUND CABLE END INTO THE CLEVIS (THREADED EYE FITTING) AND CRIMPING IT TO SEAL THE FITTING. NO THREADING OR SCREWING IN WAS INVOLVED AT THIS TIME OF MANUFACTURE. THE WOUND CABLE WAS BRAZED DIRECTLY INTO THE EYE-FITTING (CLEVIS). VISUAL INSPECTIONS AT 3 TIMES MAGNIFICATIONS REVEALED BRAZING/WELDING REMNANTS IN AND AROUND THE BREAK POINTS. SLIGHT DISCOLORATION AS A RESULT OF OXIDATION WAS OBSERVED AT THE BROKEN ENDS. IT IS UNKNOWN EXACTLY HOW THE FAILURE OCCURRED; THE BREAK DISPLAYED SIGNS OF A POSSIBLE COMBINATION OF SHEARING AND DUCTILE BREAKAGE, POSSIBLY BY REPEATED-EXCESSIVE TWISTING AND CRIMPING FORCES, THAT OCCURRED DURING ACTIVATION AND CLAMPING ACTION AS LONG TERM USAGE FATIGUE. THESE COMBINED POTENTIAL FACTORS COMBINE MAY HAVE CONTRIBUTED TO THE FAILURE MODE. NO OTHER BREAKPOINTS, DAMAGES OR SIGNS OF EXCESSIVE FORCES WERE OBSERVED ON THE CABLE WIRE ASSEMBLY. THE REST OF THE SAMPLE WAS OBSERVED TO BE NORMAL WITH NO ADDITIONAL ISSUES. CONCLUSION(S): BASED ON THE INVESTIGATION OF THE RETURNED SAMPLE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE END OF LIFE. IT SHOULD BE NOTED THAT THE SAMPLE HAS BEEN IN USE FOR 16 YEARS. END-OF-LIFE FACTORS SUCH AS REPETITIVE USAGE, WEAR, TEAR AND ANY RELATED LONG-TERM STRESS OVER THE 16 YEARS MAY HAVE CAUSED THE FAILURE MODE. IT SHOULD BE NOTED THAT OVER-FATIGUE AND EXCESSIVE TWISTING AND/OR PULLING FORCES, AND ANY IMPROPER CARE, MAINTENANCE AND/OR LACK OF LUBRICATION COULD CONTRIBUTE TO THE FAILURE MODE. THE IFU INDICATES SEVERAL PREVENTIVE MEASURES AND PRACTICES FOR THE END-USER. THE INSTRUCTIONS FOR USE STATE THAT, THE COSGROVE FLEX CLAMP SHOULD BE INSPECTED CAREFULLY PRIOR TO EACH USE AND DURING THE CLEANING PROCEDURE FOR ANY SIGNS OF UNUSUAL WEAR, CRACKING OR CORROSION. INSPECT INTERNAL CABLE FOR KINKING, FRAYING OR ANY DAMAGE TO THE CABLE. DO NOT USE IF ANY IRREGULARITY IS DETECTED. THE INSTRUMENT SHOULD BE PROPERLY LUBRICATED (MILKED) PRIOR TO STERILIZATION. THIS WILL ENSURE SMOOTH FUNCTIONING OF THE DEVICE. FOR FUTURE ISSUES OF OTHER DEVICES IT IS RECOMMENDED TO REPLACE OR REPAIR THE PARTS OF CV1161 AND OTHER COSGROVE FLEX CLAMP PRODUCTS, BY SENDING TO THE AUTHORIZED NATIONAL REPAIR CENTER: PREZIO. AT 1-800-392-6620, EMAIL: [email protected] THE SWAGED CABLE FITTING (ITEM NUMBER 99-900-070) IS A REPLACEABLE ITEM.
(B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
(B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
THE CUSTOMER REPORTED, A FLEXIBLE COSGROVE CLAMP (CV1161) BROKE IN THE OR WHILE IN USE TODAY. THE CABLE SNAPPED OFF FROM THE HANDLE, AND THE "BEADS" MAKING UP THE FLEXIBLE ARM FELL OFF INTO THE PATIENT. ALL THE PIECES WERE RETRIEVED. PATIENT X-RAYED TO CONFIRM NO BEADS WERE LEFT IN THE PATIENT. NO PATIENT HARM, NO USER HARM. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 THE CUSTOMER REPORTED, THE DATE OF THE EVENT WAS (B)(6) 2017, THE PATIENT WAS A (B)(6), MALE, (B)(6), AFTER THE EVENT HE WAS STABLE ON BYPASS, THE DATE/BODY PART, RESULT OF X-RAY: ON (B)(6) 2017, CHEST, NEGATIVE CHEST X-RAY, THE DEVICE WAS CLAMPED ONTO THE ASCENDING AORTA, THE DEVICE WAS NOT BEING MOVED OR REPOSITIONED AT THE TIME OF THE EVENT, IT WAS CLAMPED, NOT MOVING POSITION WHEN THE CABLE BROKE THE CLAMP WAS CLOSED. THE EVENT WAS RESOLVED BY REPLACING WITH ANOTHER CROSSCLAMP. THE CORONARY ARTERY BYPASS WAS THEN COMPLETED AS PLANNED. THE FACILITY WILL BE REPORTING TO THE FDA HOWEVER, NO REPORT NUMBER WAS PROVIDED.
ON (B)(6) 2017 THE CUSTOMER PROVIDED THE FDA REPORT NUMBER FROM THEIR FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606225 | COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE | CLAMP, VASCULAR | DXC | CAREFUSION, INC | CV1161 | I01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |