BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

    MDR report key: 2152771 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04819
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE NINE UNOPENED STERILE GUIDE WIRES NOTED THAT THE GUIDE WIRES WERE RETURNED COILED IN THE COIL DISPENSER INSIDE A CLEAR UNOPENED TYVEK POUCH. ALL NINE GUIDE WIRES WERE RETURNED WITH THE SAME LABEL DESCRIPTION OF PART NUMBER: 1001782-HC AND LOT NUMBER: 1041971. ALL NINE GUIDE WIRES WERE REMOVED FROM THE RETURNED COIL DISPENSERS WITHOUT RESISTANCE NOTED. THE TIPS WERE TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS FOUND NO DAMAGE TO THE RETURNED NINE UNOPENED GUIDE WIRES.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SECOND BMW GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. GUIDE WIRE SEPARATION MAY OCCUR WHEN THE WIRE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO STRETCH AND/OR DETACH. A WIRE BEING OVER PULLED OR OVER TORQUED 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. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE REPORTED SEPARATION. IN THIS CASE, ALTHOUGH THERE WAS NO REPORTED RESISTANCE, THE LESION WAS DESCRIBED AS TOTALLY OCCLUDED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED SEPARATION. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR TIP SEPARATION FOR THIS PART AND LOT COMBINATION. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, PERFORMS A NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS A 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED GUIDE WIRE TIP SEPARATION AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTALLY OCCLUDED RIGHT CAROTID ARTERY INTERVENTIONAL PROCEDURE, WHEN THE BMW WIRE WAS REMOVED FROM THE ANATOMY, THE TIP WAS SHEARED OFF. THERE WERE NO SIGNS OF THE TIP IN THE BODY. IT IS UNKNOWN WHEN THE TIP SHEARED. NO RESISTANCE WAS FELT. A SECOND BMW WAS USED WITH A NON-ABBOTT BALLOON. THE BALLOON BECAME STUCK ON THE WIRE. IT COULD NOT ADVANCE OR BE REMOVED, SO BOTH DEVICES (WIRE AND BALLOON) WERE REMOVED AS ONE UNIT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ANOTHER BMW WIRE WAS USED WITHOUT ISSUE. ALTHOUGH REQUESTED, THERE WAS NO ADDTIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI GUIDE WIRE DQX AV-TEMECULA-CT 1041971

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability