BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 2101044 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03660
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K980119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. ESTIMATED DATES (REPORTED AS HAVING OCCURRED SOMETIME IN (B)(6)). DEVICE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. POTENTIAL FACTORS WHICH COULD CAUSE RESISTANCE IN A GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMY AND MORPHOLOGY, DAMAGE TO THE GUIDE WIRE, OBSTRUCTIONS TO THE INNER DIAMETER OF THE GUIDE CATHETER, KINKS OR BENDS IN THE GUIDING CATHETER, COAGULATION OF BLOOD OR CONTRAST IN THE GUIDING CATHETER AND/OR ON THE GUIDE WIRE. MANUFACTURING ANOMALIES COULD ALSO BE A POSSIBLE FACTOR; HOWEVER, MANUFACTURING PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL GUIDE WIRES PRIOR TO PACKAGING. IN THIS CASE, THERE WAS NO NOTE OF ANY DAMAGE TO THE GUIDE WIRE PRIOR TO THE PROCEDURE WHICH MAY SUGGESTS THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTY. OVERALL, WITHOUT HAVING THE GUIDE WIRE TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AS A GENERAL COMMENT THAT SUPRACORE GUIDE WIRES HAVE MET RESISTANCE DURING ADVANCEMENT AND REMOVAL THROUGH 5 FR TAPERED TIP NON-ABBOTT GUIDING CATHETERS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE NUMBER OF DEVICES, CASES OR PATIENTS IS UNKNOWN. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: 5 FRTRAILBLAZERS