BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFORCE¿ PERIPHERAL CROSSING SET

    MDR report key: 9225286 · Received October 23, 2019

    Report

    Report Number
    1820334-2019-02674
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 12, 2019
    Report Date
    December 2, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002564169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D11: CONCOMITANT PRODUCTS - 9 FR. PERFORMER INTRODUCER SET, .035 WIRE GUIDE (BRAND & LENGTH UNSPECIFIED), ATLAS 14MM DIAMETER BY 4CM LENGTH, ZILVER VENA 14*140 STENT. INVESTIGATION/EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGED CONFIRMED THAT A USED KCXS-5.0-35-100-RB-0/0-HC SET INCLUDING 1 CXI CATHETER AND 1 FLEXOR SHEATH WAS RETURNED TO COOK FOR INVESTIGATION. ANOTHER USED CXI CATHETER FROM A KCXS-5.0-35-100-RB-0/0-HC SET WAS RETURNED AS WELL; THE FLEXOR SHEATH FROM THIS SET WAS NOT RETURNED. BOTH RETURNED CXI¿S WERE KINKED. THE FIRST CXI HAD KINKS LOCATED AT 97.5CM, 98.7CM, AND 99.4CM FROM THE STRAIN RELIEF. THE SECOND CXI HAD KINKS LOCATED AT 68.4CM AND 99.5CM FROM THE STRAIN RELIEF. NONE OF THE KINKS HAD SHARP EDGES. THE RETURNED FLEXOR WAS ALSO KINKED, AND THE KINK WAS LOCATED AT 65.2CM FROM THE CHECK-FLO HUB. IT WAS CONFIRMED THAT THE FLEXOR SHEATH TIP WAS DAMAGED, AS THE TIP WAS SPLIT, JAGGED, AND OUT OF ROUND. ADDITIONALLY, THE SHEATH ENDHOLE WAS NOT SMOOTH. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. HOWEVER, A REVIEW OF THE SUBASSEMBLY LOT DID NOTE TWO POTENTIALLY RELATED NONCONFORMANCES. IT SHOULD BE NOTED THAT THE AFFECTED UNITS WERE SCRAPPED AND NOT REPLACED. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES ¿THE DEVICE SHOULD NOT BE ADVANCED INTO A VESSEL HAVING A REFERENCE VESSEL DIAMETER SMALLER THAN THE SHEATH OUTER DIAMETER.¿ THE IFU GOES ON TO SAY, ¿THE DEVICE SHOULD NOT BE FORCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION.¿ BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THIS EVENT CANNOT BE TRACED TO THE DEVICE BUT TO THE PATIENT¿S CONDITION. REPORTEDLY, THE TARGET LESION WAS TORTUOUS AND FIBROTIC. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05NOV2019 NOTING THAT THE PROCEDURE BEING PERFORMED WAS A CHRONIC ILIOFEMORAL OUTFLOW OBSTRUCTION. THE FLEXOR SHEATH SPLIT WHILE TRYING TO CROSS THE LESION. REPORTEDLY, THE PHYSICIAN NOTED THAT THERE WAS ONE LOCATION WHERE HE WAS TRYING TO CROSS AND "YOU COULD SEE THE FLEXOR TIP GET 'HUNG UP' ON THE LESION". ADDITIONALLY, RESISTANCE DURING INSERTION OR RESISTANCE WAS NOT NOTED. PRIOR TO USE, THE SHEATH WAS ADEQUATELY PREPPED AND FLUSHED, AND THE HYDROPHILIC COATING WAS ACTIVATED. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY OTHER COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K170931. DEVICE EVALUATED BY MFG = DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS INITIALLY REPORTED, DURING AN UNKNOWN PROCEDURE, A TRIFORCE¿ PERIPHERAL CROSSING SET TIP WAS DAMAGED (A NON-REPORTABLE EVENT). UPON RECEIPT AND INITIAL EVALUATION OF THE DEVICE ON 18OCT2019, THE TIP WAS FOUND TO BE SPLIT. NON-SHARP KINKS WERE ALSO NOTED UPON RETURN (A NON-REPORTABLE FINDING). THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019461 TRIFORCE¿ PERIPHERAL CROSSING SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G56416 9763941 00827002564169

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10