BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFORCE¿ PERIPHERAL CROSSING SET

    MDR report key: 9667157 · Received February 4, 2020

    Report

    Report Number
    1820334-2020-00281
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 14, 2020
    Report Date
    April 9, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002564152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING A RECANULIZATION PROCEDURE OF THE FEMORAL VEIN INVOLVING A PATIENT WITH DEEP VEIN THROMBOSIS, A TRIFORCE PERIPHERAL CROSSING SET SHEATH KINKED UPON ADVANCEMENT INTO A CHRONIC CLOT. ACCESS WAS OBTAINED IN THE BACK OF THE LEG. THE ANATOMY WAS REPORTED TO BE CALCIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S SHEATH, USING THE CATHETER INCLUDED WITH THE TRIFORCE PERIPHERAL CROSSING SET. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 03FEB2020, THE SHEATH WAS NOTED TO BE PARTIALLY SEPARATED IN TWO PLACES. THE TIP WAS ALSO NOTED TO BE DAMAGED. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND PERSONNEL INTERVIEW WAS CONDUCTED DURING THE INVESTIGATION. IN ADDITION, A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS PERFORMED. THE PHYSICAL INSPECTION OF THE COMPLAINT DEVICE FOUND THAT THE COMPLAINT SHEATH WAS RETURNED WITH BIO-MATTER PRESENT AND AN EXPRESS LD BOSTON SCIENTIFIC BALLOON CATHETER. THE SHEATH IS KINKED 6.5 CM FROM DISTAL TIP AND IS CRACKED WITH PARTIAL SEPARATION AT 8.8 CM AND 10.3 CM. THE RADIOPAQUE TIP OF THE SHEATH WAS ALSO NOTED TOO BE DAMAGED. THE OUTER DIAMETER OF THE BOSTON SCIENTIFIC BALLOON WAS MEASURED TO BE 0.075 INCHES. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO FAILURE RELATED NONCONFORMANCES. A COMPLAINT SEARCH REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. EVIDENCE FROM THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, VALIDATIONS, MANUFACTURING DOCUMENTS, AND DEVICE FAILURE ANALYSIS SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT IFU STATES ¿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." IT ALSO INSTRUCTS ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ A PREVIOUS CAPA HAS CONCLUDED THAT SEPARATION FAILURES OF THIS DEVICE ARE BASED UPON USE OF THE DEVICE; WITH CONTRIBUTING FACTORS FOR SIMILAR EVENTS INCLUDING THE ABILITY TO ADVANCE THESE DEVICES INTO RESTRICTIVE ANATOMIES AND FAILURE TO REINSERT THE DILATOR INTO THE SHEATH PRIOR TO REMOVAL. AN ONGOING CAPA IS IN PLACE TO INVESTIGATE THIS FAILURE MODE. INVESTIGATION HAS CONCLUDED THAT BASED ON THE INFORMATION PROVIDED AND INSPECTION OF THE COMPLAINT DEVICE, THE CAUSE OF THIS EVENT IS RELATED TO THE PATIENT¿S CALCIFIED ANATOMY. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    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 REPORTED, DURING A RECANALIZATION PROCEDURE OF THE FEMORAL VEIN INVOLVING A PATIENT WITH DEEP VEIN THROMBOSIS, A TRIFORCE PERIPHERAL CROSSING SET SHEATH KINKED UPON ADVANCEMENT INTO A CHRONIC CLOT. ACCESS WAS OBTAINED IN THE BACK OF THE LEG. THE ANATOMY WAS REPORTED TO BE CALCIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S SHEATH, USING THE CATHETER INCLUDED WITH THE TRIFORCE PERIPHERAL CROSSING SET. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 03FEB2020, THE SHEATH WAS NOTED TO BE PARTIALLY SEPARATED IN TWO PLACES. THE TIP WAS ALSO NOTED TO BE DAMAGED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127771 TRIFORCE¿ PERIPHERAL CROSSING SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G56415 9810979 00827002564152

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO DESTINY SHEATH