BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F M-I STIFFEN 40CM NT-SS (610366)

    MDR report key: 2437695 · Received January 10, 2012

    Report

    Report Number
    1649395-2012-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    November 23, 2011
    Report Date
    December 19, 2011
    Manufacturer
    GALT MEDICAL CORP.
    Product Code
    DQX
    PMA / PMN Number
    K982559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED. INVESTIGATION INDICATES THAT THE SETS WERE MFG ACCORDING TO SPECIFICATION. NO DISCREPANCIES OR NONCONFORMITIES RELATED TO THE COMPLAINT WERE FOUND WITHIN THE MFG OF THESE PRODUCTS. IT WAS DETERMINED, BASED ON THE ANALYSIS OF THE RETURNED PRODUCT; THE REPORTED COMPLAINT OF THE FRACTURED WIRE WAS A RESULT OF OVERLY AGGRESSIVE HANDLING. THIS ASSESSMENT IS SUPPORTED BY THE STATE OF THE COAXIAL DILATOR (510K# K000737), IN WHICH THE CONDITION IS CONSISTENT WITH EXCESSIVE FORCE DURING THE INSERTION OF THE DEVICE. THE PARTICULAR COAXIAL DILATOR IS "STIFFENED", THEREFORE WOULD ONLY ARRIVE IN THIS CONDITION THROUGH ROUGH AND INAPPROPRIATE HANDLING. AS STATED IN THE KIT INSTRUCTIONS CAUTIONS: "IF RESISTANCE IS MET WHEN ADVANCING OR WITHDRAWING THE GUIDEWIRE OR THE MICRO-INTRODUCER, DETERMINE THE CAUSE BY FLUOROSCOPY AND CORRECT BEFORE CONTINUING WITH THE PROCEDURE. BECAUSE OF THE DELICATE AND FRAGILE NATURE OF GUIDEWIRES, EXTRA CARE IN HANDLING MUST BE TAKEN". (B)(6).

    Description of Event or Problem · 1

    (B)(4). THE MD MADE A SMALL SKIN INCISION AND USING THE 4FR SUPPLIED MICROWIRE DILATOR, THE MD ATTEMPTED TO INSERT THIS IN THE VESSEL FOR APPROX 3 CMS INTO THE BODY, HOWEVER WITH FURTHER ADVANCEMENT, THERE WAS A SLIGHT RESISTANCE. MD PULLED THE WIRE AND SHEATH AS A UNIT. THE WIRE HAD FRACTURED CLEANLY APPROX 1 CM OUTSIDE THE LUMEN OF THE INNOMINATE. FRAGMENT WAS NOT REACHABLE BY THE SURFACE AND IT DID NOT PROTRUDE. AN 1 CM INCISION WAS MADE OVER THE INSERTION SITE, BUT THE WIRE WAS NOT ABLE TO BE RETRIEVED USING FLUOROSCOPY. GROIN ACCESS WAS OBTAINED WITH ATTEMPTS TO SNARE UNSUCCESSFUL. VASCULAR SURGEON WAS ABLE TO RETRIEVE THE WIRE VIA A LENGTHENED SHOULDER INCISION. PROCEDURE WAS IMPLANT OF TEMPORARY PACEMAKER. PT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4F M-I STIFFEN 40CM NT-SS (610366) 4F MICRO INTRODUCER KIT DQX GALT MEDICAL CORP. NA F0712411

    Patients

    Seq Age Sex Outcome Treatment
    1