BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM

    MDR report key: 8765098 · Received July 5, 2019

    Report

    Report Number
    1820334-2019-01625
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 10, 2019
    Report Date
    August 15, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002478251
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF DOCUMENTATION INCLUDING THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED WIRE GUIDE WAS RETURNED FOR INVESTIGATION. UPON A PHYSICAL EXAMINATION, BIOLOGICAL MATTER WAS NOTED ON THE DEVICE. THE WELD BALL ON THE STRAIGHT END OF THE WIRE WAS FOUND TO BE BROKEN. A BEND WAS NOTED ON THE WIRE GUIDE, AND IT WAS FOUND TO BE SEVERELY ELONGATED FOR 26.5CM. DIMENSIONAL ANALYSIS CONFIRMED THAT THE DEVICE AND COMPONENTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. THE WIRE GUIDE WAS FOUND TO BE BENT, CURLED, ELONGATED AND THE WELD BALL TO BE BROKEN. BECAUSE OF THE DAMAGE TO THE WIRE GUIDE THERE IS EVIDENCE TO SUGGEST THE DEVICE MAY HAVE BEEN MANUFACTURED OUT OF SPECIFICATION. BECAUSE THE WIRE GUIDE WAS DAMAGED IN MULTIPLE LOCATIONS FOR MULTIPLE CAUSES THE COMPLAINT CAN BE CONFIRMED ON THE RETURNED DEVICE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY FILE FOR LOT 8974460 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE FAILURE MODE. IT SHOULD BE NOTED THAT THERE WAS AN ADDITIONAL COMPLAINT REPORTED FOR THIS LOT FROM THE SAME CUSTOMER WITH THE SAME FAILURE MODE. THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING PRODUCT EXISTS HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: ¿SLIDE SAFE-T-J® WIRE GUIDE STRAIGHTENER (POSITIONED ON DISTAL TIP OF WIRE GUIDE) OVER ¿J¿ PORTION OF WIRE GUIDE. PASS STRAIGHTENED WIRE GUIDE THROUGH NEEDLE; ADVANCE WIRE GUIDE 5-10CM INTO VESSEL. IF STRAIGHT WIRE IS USED, ALWAYS ADVANCE SOFT, FLEXIBLE END THROUGH NEEDLE HUB AND INTO VESSEL. IF RESISTANCE ENCOUNTERED DURING WIRE GUIDE INSERTION, DO NOT FORCE WIRE GUIDE. WITHDRAWAL OF WIRE GUIDE THROUGH NEEDLE SHOULD BE AVOIDED; BREAKAGE MAY RESULT.¿ HOW SUPPLIED: ¿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.¿ BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CAN BE TRACED TO THE USER AND A FAILURE TO FOLLOW INSTRUCTIONS. BASED ON THE INFORMATION PROVIDED TO COOK, THE DEVICE WAS USED IN A MANNER THAT IS INCONSISTENT WITH THE PRODUCT LABELLING. SPECIFICALLY, THE WIRE GUIDE WAS WITHDRAWN THROUGH THE NEEDLE. COOK RECOMMENDS AGAINST THIS ACTION AS WITHDRAWING THE WIRE GUIDE THROUGH A NEEDLE MAY CONTRIBUTE TO THE WIRE GUIDE BREAKING. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. (B)(6). 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

    IT WAS REPORTED THAT AFTER ADVANCING THE WIRE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET INTO THE SUBCLAVIAN VESSEL OF THE PATIENT, THE PHYSICIAN EXPERIENCED DIFFICULTY AS THE WIRE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE NEEDLE. BOTH THE WIRE AND THE NEEDLE WERE THEN WITHDRAWN TOGETHER, AND THE PHYSICIAN NOTED THAT THE WIRE APPEARED "DEFORMED." A LIKE DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE. UPON PRELIMINARY EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE WIRE WAS UNRAVELED AND ELONGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558218 COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A 8974460 00827002478251

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR