BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 2801671 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06684
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION AND SEM IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED, ANTERIOR TIBIA ARTERY. A BALANCE HEAVYWEIGHT (BHW) WAS ADVANCED TO THE LESION, A NON-ABBOTT THROMBECTOMY CATHETER WAS ADVANCED AND A NON-ABBOTT ANGIOJET MACHINE WAS USED TO REMOVE THE THROMBUS. THE NON-ABBOTT THROMBECTOMY CATHETER WAS REMOVED AND ANGIOGRAPHY WAS PERFORMED. THE SAME NON-ABBOTT THROMBECTOMY CATHETER WAS AGAIN ADVANCED AND MORE THROMBUS WAS REMOVED. THE PHYSICIAN TRIED TO MANIPULATE THE GUIDE WIRE; HOWEVER, IT FELT SLACK. THE GUIDE WIRE WAS REMOVED BUT ONLY THE PROXIMAL END CAME OUT OF THE ANATOMY. IT HAD SEPARATED APPROXIMATELY 30 CM PROXIMAL TO THE TIP. THE SEPARATED PORTION WAS REMOVED WITH THE NON-ABBOTT THROMBECTOMY CATHETER THAT WAS STILL IN THE ANATOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 2032771

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER: ANGIOJET, THROMBECTOMY CATHETER