BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2941564 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00606
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A NON-ABBOTT GUIDE WIRE WAS PLACED ACROSS THE DISLODGED WIRE FRAGMENT AND INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY; A SNARE WAS USED TO RETRIEVE THE FRAGMENT AND REMOVE IT FROM THE ANATOMY. FINAL ANGIOGRAPHY SHOWED EXCELLENT LAD AND OM1 DISTAL FLOW; VITAL SIGNS WERE ALL STABLE AND THE PATIENT WAS TRANSFERRED FROM THE CATH LAB. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. IT WAS NOTED THAT THE PATIENT IS SCHEDULED FOR AN ADDITIONAL PROCEDURE OF THE LAD ARTERY WHEN THE VITAL SIGNS AND KIDNEY FUNCTION RETURN TO NORMAL. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DIL CATH: SPRINTER 2.0X12MM, HIRYU 2.5X10MM, QUANTUM MAVERICK 2.0X12MM; 1.25X12MM AND 1.5X10MM TAZUNA, GUIDE WIRE: BMW UII 190CM; 0.014 RINATO WIRE, GUIDE CATH: 6FR EBU3.5, OTHER: MULTISNARE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A CINE OF THE PROCEDURE WAS RETURNED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THAT THE IMAGES WERE CONSISTENT WITH THE WIRE TIP FRAGMENTATION. ONE LIKELY CAUSE FOR THE SEPARATION IS METAL FATIGUE DUE TO THE CYCLIC BENDING OF THE WIRE TIP AS WELL AS PLACEMENT IS A TIGHT BRANCH. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE ESTATIC, ECCENTRIC, 99% STENOSED, DE NOVO MID CIRCUMFLEX (LCX) AND OBTUSE MARGINAL (OM1) ARTERIES, THE 6 FR NON-ABBOTT GUIDE CATHETER WAS USED TO ENGAGE THE LEFT MAIN AND A 0.014 NON-ABBOTT GUIDE WIRE WAS PLACED AT THE OM1 WITH A BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE AT CIRCUMFLEX. THE OM1 WAS PREDILATED WITH A 2.0 X 12 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC) AT 12-14 ATMOSPHERE (ATM). THE CIRCUMFLEX WAS DILATED WITH A 1.25 X 12 MM AND A 1.5 X 10 MM NON-ABBOTT BDC THEN WITH THE 2.0 X 12 MM BDC. IT WAS NOTED THAT DUE TO ANATOMICAL DIFFICULTY THE 2.0 X 12 MM BDC PLACED AT THE OM1 WAS USED FOR THE ANCHORING TECHNIQUE [AND TO STRAIGHTEN THE LCX] SO THE 1.25 X 12 MM BDC COULD BE USED TO PREDILATE THE LCX. A 2.5 X 12 MM NON-ABBOTT STENT WAS DEPLOYED AT THE PROXIMAL LCX-OM1. A 0.014 NON-ABBOTT GUIDE WIRE WAS RE-CROSSED TO THE LCX THROUGH THE STENT STRUT TO OPEN UP/STRETCH IT AND DILATED THE LCX WITH A 2.0 X 12 MM BDC. POST DILATATION OF THE STENT WITH A 2.5 X 10 MM BDC AT 12-18 ATM WAS PERFORMED SUCCESSFULLY. FINALLY, A KISSING BALLOON TECHNIQUE WITH THE SAME BALLOON AT EACH ARTERY AT NOMINAL PRESSURE WAS PERFORMED WITHOUT ISSUE. THE PATIENT'S ST-DEPRESSION ECG CHANGED TO NORMAL. AT THE END OF THE PROCEDURE THE PHYSICIAN ATTEMPTED TO REMOVE THE BMWUII, HOWEVER, THE DISTAL TIP HAD BECOME DETACHED. APPROXIMATELY 22 MM REMAINED AT THE LEFT MAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47199 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091471

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention