BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2808958 · Received October 30, 2012

    Report

    Report Number
    2024168-2012-06855
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE WIRE: RUNTHROUGH HC; GUIDE CATH: TAIGA 6F AL1.5; STENT: PROMUS ELEMENT 3.0 X 16 MM. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED GUIDE WIRE DETACHMENT AND STRETCHED COILS WERE CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE REPORTED DIFFICULT TO REMOVE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON VISUAL ANALYSIS AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT UPDATED INFORMATION RECEIVED FROM THE ABBOTT CLINICAL REVIEW OF THE 2 CDS RECEIVED STATES THAT THE IMAGES CONFIRM THAT THE TIP OF THE ELITE WIRE WAS DAMAGED DURING THE PROCEDURE. THIS MAY HAVE BEEN DUE TO AN ACCORDION AFFECT RESULTING IN METAL FATIGUE. THE DAMAGE MAY HAVE BEEN EXACERBATED WITH REMOVAL WHEN ENTRAPPED BETWEEN THE DEPLOYED STENT AND THE VESSEL WALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY CALCIFIED, DE NOVO, 90% STENOSED, LEFT MAIN (LM) AND MILDLY CALCIFIED, DE NOVO, 90% STENOSED, CONCENTRIC, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERIES, A NON-ABBOTT STENT WAS IMPLANTED MID TO DISTAL LAD; PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FROM THE LM TO THE MID LAD. A NON-ABBOTT GUIDE WIRE CROSSED TO THE LAD AND A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS CROSSED TO THE DISTAL LAD/THE FIRST DIAGONAL BRANCH AS A PROTECTION. A 3.0 X 16 NON-ABBOTT STENT WAS IMPLANTED IN THE LESION FROM THE LM TO THE MID LAD OVERLAPPING ABOUT 2 MM WITH THE JUST PLACED NON-ABBOTT STENT AT 14 ATMOSPHERE (ATM). WHEN AN ATTEMPT WAS MADE TO REMOVE THE BMW ELITE GUIDE WIRE IN THE DISTAL LAD/THE FIRST DIAGONAL BRANCH, THE TIP DID NOT MOVE. THE GUIDE WIRE WAS PULLED AND THE COILS WERE OBSERVED UNDER ANGIOGRAPHY TO BE STRETCHED. THE CORE SEPARATED 1-2 CM PROXIMAL TO THE DISTAL END, HOWEVER, THE ENTIRE GUIDE WIRE AND THE ATTACHED DISTAL TIP FRAGMENT WAS REMOVED WHEN THE DEVICE WAS PULLED FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONALLY, 2 PROCEDURE CDS WERE RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL. EACH CD SHOWS A DIFFERENT VIEW OF THE SAME PROCEDURE. THE REVIEWER CONCLUDED THAT THE IRREGULAR APPEARANCE OF THE GUIDE WIRE SUGGESTS THAT THE COILS WERE IRREGULAR; PERHAPS STRETCHED OR UNRAVELED. THIS WOULD CONFIRM THE INCIDENT DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091401

    Patients

    Seq Age Sex Outcome Treatment
    1