BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2941568 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00608
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 28, 2012
    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. AN ATTEMPT WITH A NON-ABBOTT GOOSENECK MICROSNARE WAS UNSUCCESSFUL IN RETRIEVING THE FRAGMENT AND TIMI FLOW WAS REDUCED WITH ST ELEVATED. ABCIXIMAB MEDICATION WAS GIVEN AND GOOD FLOW WAS RESTORED. A SECOND ATTEMPT WAS UNSUCCESSFUL IN SNARING THE FRAGMENT AND THE PROCEDURE WAS DISCONTINUED. THE PATIENTS VITAL SIGNS WERE REPORTED AS STABLE AND THE PATIENT WAS TRANSFERRED FROM THE CATH LAB. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DIL CATH: SPRINTER 2.5X15MM, NC SPRINTER 2.75X12MM; PANTERA BALLOON 2.5X10MM; QUANTUM MAVERICK 2.5X8MM. GUIDE CATHETER: 6FR EBU4.0. GUIDE WIRE: 0.014 RINATO (X2); WHISPER MS 190CM. 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 RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THAT THE IMAGES ARE CONSISTENT WITH WIRE TIP FRAGMENTATION. ONE POSSIBLE CAUSE FOR THE FRACTURE IS METAL FATIGUE SECONDARY TO THE CYCLIC BENDING WITH ASYSTOLE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE ECCENTRIC, ECSTATIC, 95% STENOSED, DE NOVO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, A 6 FR 3.5 NON-ABBOTT GUIDE CATHETER WAS ATTEMPTED BUT LACKED SUPPORT AND WAS REPLACED WITH A 6 FR 4.0 NON-ABBOTT GUIDE CATHETER. THE LEFT MAIN (LM) WAS ENGAGED AND A 0.014 BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE WAS PLACED TO THE LAD. THE LAD LESION WAS PREDILATED WITH A 2.5 X 15 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC) THEN THE SAME 0.014 NON-ABBOTT GUIDE WIRE CROSSED THE D2 LESION AND THE 2.5 X 15 MM BDC WAS USED FOR PREDILATATION. A 2.75 X 18 MM NON-ABBOTT STENT WAS DEPLOYED AT THE MID LAD. A DIFFERENT 0.014 GUIDE WIRE WAS POSITIONED AT D2 ACROSS THE LAD STENT STRUT AND THE FIRST GUIDE WIRE WAS REMOVED. THE D2 LESION WAS DILATED AGAIN WITH THE 2.5 X 15 MM BDC AND POST-DILATED WITH A 2.75 X 12 MM NON-COMPLIANT NON-ABBOTT BDC. THE D2 GUIDE WIRE WAS REMOVED AND PLACED AT THE CIRCUMFLEX (LCX) ARTERY. A 2.5 X 10 MM NON-ABBOTT BDC WAS USED TO PREDILATE THE PROXIMAL LCX LESION AND A 2.5 X 12 MM XIENCE PRIME STENT WAS DEPLOYED AT THE PROXIMAL LCX. POST DILATATION OF THE LCX STENT WAS DONE WITH A 2.5 X 8 MM NON-ABBOTT BDC. THE FINAL ANGIOGRAPHY SHOWED EXCELLENT LAD, D2, AND LCX FLOW. THE BMWUII GUIDE WIRE WAS REMOVED FROM THE LAD BUT THE DISTAL TIP WAS NOTED TO HAVE DETACHED; AN APPROXIMATELY 22.40 MM FRAGMENT REMAINED IN THE ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46171 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2101071

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R