BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALEO F 14

    MDR report key: 1120872 · Received August 15, 2008

    Report

    Report Number
    1028232-2008-00919
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    March 24, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DQX
    PMA / PMN Number
    K982272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE RETURNED INSTRUMENT UNDERWENT A DETAILED TECHNICAL ANALYSIS. IN ADDITION, THE ASSOCIATED PRODUCTION DOCUMENTATION WAS EXAMINED TO DETERMINE WHETHER THERE MIGHT HAVE BEEN A DEVIATION IN THE MFG PROCESS AS THE CAUSE. THE BREAK-OFF SITE OF THE WIRE TIP COULD BE LOCALIZED DIRECTLY DISTAL TO THE CONTROL TRANSMISSION POINT (CTP), ABOUT 30 MM FROM THE TIP. THE BREAK-OFF SITES OF THE WIRE WERE STUDIED WITH A SCANNING ELECTRON MICROSCOPE (SEM). THE IMAGES OF THE PROXIMAL FRACTURE SITE HAVE SHOWN THAT THE BREAK-OFF MUST MOST LIKELY HAVE BEEN CAUSED BY EXCESSIVE BENDING STRESS, WHICH CAN BE DEDUCED FROM THE STRUCTURE OF THE FRACTURE SITE. THE REVIEW OF THE PRODUCTION DOCUMENTS DID NOT SHOW ANY DEVIATIONS IN THE MFG PROCESS. THE PROD HAD BEEN PRODUCED ACCORDING TO SPECS AND MET ALL REQUIREMENTS OF THE IN-PROCESS AND FINAL INSPECTION. THE FRACTURE OF THE WIRE IS WITH HIGH PROBABILITY DUE TO A MECHANICAL OVERLOAD. A MATERIAL-RELATED CAUSE CAN BE RULED OUT BASED ON THE ANALYSIS.

    Description of Event or Problem · 1

    OUS MDR. A LESION IN THE TORTUOUS VESSEL SECTION THAT NEEDED TREATMENT WAS A DISTAL LESION IN THE LAD WITH A LENGTH OF 20 MM, A VESSEL DIAMETER OF 3 MM, AND A STENOSIS DEGREE OF 90%. AS REPORTED BY THE CLINIC, THE GALEO GUIDE WIRE COULD BE ADVANCED THROUGH THE VERY TORTUOUS VESSEL COURSE UP UNTIL A SHORT DISTANCE BEFORE THE DISTAL STENOSIS WITHOUT DIFFICULTIES. RIGHT BEFORE THE RESPECTIVE DISTAL STENOSIS, THE SOFT WIRE TIP BROKE OFF FROM THE REST OF THE WIRE. THE WIRE WAS RETRACTED AND THE TIP OF THE WIRE COULD BE RETRIEVED WITH THE HELP OF A CATCH LOOP. NO INJURY TO THE PT WAS REPORTED. PLEASE NOTE THAT THERE ARE NO SERIAL NUMBERS FOR GALEO, ONLY BATCH NUMBERS, WHICH IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALEO F 14 GUIDEWIRE DQX BIOTRONIK GMBH AND CO 115487

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization