BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2042505 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02414
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE THAT THE TIP BECAME BENT DURING REMOVAL FROM THE PACKAGING. A GUIDE WIRE MIX UP AT ABBOTT VASCULAR OR AT THE ACCOUNT WAS VERY UNLIKELY AS A RECORD OF GUIDE WIRES SHIPPED TO THE ACCOUNT WAS REVIEWED AND IT WAS DETERMINED THAT NO J SHAPED WIRES FROM THIS PART AND LOT HAVE BEEN SHIPPED TO THE ACCOUNT. THEREFORE, A POTENTIAL MIX UP AT THE ACCOUNT WAS NOT LIKELY. MANUFACTURING CONFIRMED THAT THERE WERE NO J SHAPE GUIDE WIRES BUILT DURING THE SAME TIME AS THE GUIDE WIRES FROM THIS LOT. THEREFORE, THE POSSIBILITY OF A GUIDE WIRE MIX UP DURING MANUFACTURING WAS ALSO NOT LIKELY. THE TIP SHAPE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT AND IS NOT RELATED TO A PRODUCT DEFICIENCY. THE REPORTED J SHAPED TIP WAS LIKELY A DAMAGED TIP. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO GUIDE WIRE TIP DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE DURING SHIPPING AND/OR STORAGE, REMOVAL FROM COIL DISPENSER, AND HANDLING DURING PREPARATION FOR USE OR DURING THE PROCEDURE. TO ENSURE GUIDE WIRE TIP DAMAGE DOES NOT OCCUR AS A RESULT OF A PRODUCT DEFICIENCY, MANUFACTURING PERFORMS A 100% VISUAL INSPECTION OF THE WIRE PRIOR TO PACKAGING AND AFTER THEY ARE LOADED INTO THE DISPENSER. QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY THE PRODUCT QUALITY. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND INDICATES THAT THIS LOT MET ALL MANUFACTURING RELEASE REQUIREMENTS AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. MANUFACTURING ALSO REVIEWED THE MANUFACTURING RECORDS FOR THIS LOT AND THERE WERE NO SCRAPPED PARTS FOR TIP DAMAGE DURING THE 100% INSPECTION OF THE GUIDE WIRE TIPS. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. THEREFORE, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONCE THE BALANCE HEAVY WEIGHT (BHW) GUIDE WIRE WAS REMOVED FROM THE PACKAGE, THE TIP ALREADY HAD A "J" CURVE ON IT THAT THEY DID NOT NEED FOR THIS CASE. THE DEVICE PACKAGE INDICATED THE BHW SHOULD HAVE BEEN A STRAIGHT TIP. THERE WAS NO PATIENT INVOLVEMENT. A SECOND BHW WAS USED WITHOUT FURTHER INCIDENT. THERE WAS NO ADDITIONAL INFORMATION 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 0061181

    Patients

    Seq Age Sex Outcome Treatment
    1