BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER LS GUIDE WIRE

    MDR report key: 1884483 · Received October 19, 2010

    Report

    Report Number
    2024168-2010-02192
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE GUIDE WIRE FOUND IT WAS RETURNED WITHOUT BLOOD OR CONTRAST VISIBLE WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING WIPED DOWN PRIOR TO SHIPMENT TO ABBOTT VASCULAR FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED 23.7 CM DISTAL TO THE PROXIMAL END OF THE BLACK POLYMER COATING. THE SEPARATED PORTION WAS RETURNED FOR A LENGTH OF 5.5 CM. THE BLACK POLYMER COATING WAS JAGGED AT THE SEPARATION. THE SEM (SCANNING ELECTRON MICROSCOPE) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. FOR THE GUIDE WIRE TO FAIL IN THIS MANNER, THE GUIDE WIRE WOULD BE OVER BENT BY PUSHING OR PULLING OR OVER TORQUED BY TURNING AND WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN PRODUCTS CAN ALL BE FACTORS. ANY ATTEMPTS TO MOVE THE GUIDE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSE THE REPORTED SEPARATION. IN THIS CASE, ALTHOUGH REQUESTED, ANATOMICAL INFORMATION WAS NOT PROVIDED WHICH MAY HAVE AIDED IN THE EVALUATION. IT WAS REPORTED THAT ADDITIONAL THERAPY/NON-SURGICAL TREATMENT WAS USED TO RETRIEVE THE SEPARATED PORTION WITH A SNARE DEVICE. ANALYSIS ALSO NOTED A BEND IN THE CORE, 1 CM PROXIMAL TO THE SEPARATION. THERE WAS A KINK IN THE CORE 17 CM PROXIMAL TO THE SEPARATION AND TWO KINKS IN THE TIP, 1 CM AND 1.1 CM PROXIMAL TO THE TIP BALL. THE NOTED BEND AND KINKS LIKELY OCCURRED DURING THE PROCEDURE AND/OR SHIPMENT POST PROCEDURE AS NO DAMAGE WAS NOTED PRIOR TO USE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS REPORT. IN ORDER TO ENSURE THAT GUIDE WIRE SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A NON DESTRUCTIVE PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. OVERALL, THE REPORTED GUIDE WIRE SEPARATION, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, REMOVAL OF FOREIGN BODY USING A SNARE DEVICE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A F/U REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 2 OF 4. THE REGISTERED NURSE (RN) STATED THAT THE BAG FELL AND DISCONNECTED. GTS HAD THE RN CYCLE POWER TO DISPLAY PRESS GO TO START. THE RN WAS GOING TO RESTART WITH NEW SUPPLIES. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IN THE CORONARY SINUS, WHEN THE END OF THE WHISPER GUIDE WIRE SEPARATED. THE DEVICE WAS REMOVED FROM THE PT WITH NO REPORTED EFFECTS. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT OF THE SAME DEVICE. NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER LS GUIDE WIRE GUIDE WIRES DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9110691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention