BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 1843065 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04479
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    May 21, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED A VERY SMALL LENGTH OF BRAIDING WAS EXPOSED INSIDE THE DISTAL TIP AND DAMAGE WAS NOTED TO THE INNER LINING AND A SMALL PORTION OF THE EXTERIOR OF THE DISTAL TIP. INNER DIAMETER (ID) MEASUREMENTS AT THE DISTAL TIP AND THE PROXIMAL END WERE FOUND TO MEET SPECIFICATIONS. EXAMINATION OF THE MATERIAL SURROUNDING THE TIP DAMAGE AND INTERNAL DAMAGE DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE OR THE REPORTED EVENT. MICROSCOPIC EXAMINATION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-02882. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A RENAL STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT RENAL ARTERY. THE 6.0X14X150CM EXPRESS SD BILIARY STENT SYSTEM WAS ADVANCED TO THE LESION AND THE STENT WAS SUCCESSFULLY DEPLOYED IN THE VESSEL. UPON REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), THE BALLOON BECAME CAUGHT ON THE STENT. THE PHYSICIAN UTILIZED THE 6FR MACH 1 JR 3.5 GUIDE CATHETER TO PULL THE BALLOON AWAY FROM THE STENT. AFTER FOUR ATTEMPTS, THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE STENT; HOWEVER, HE WAS STILL UNABLE TO PULL THE SDS INTO THE GUIDE CATHETER. THE SDS AND THE GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED EXPOSED BRAIDING AND DAMAGE TO THE INNER LINING OF THE GUIDE CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749343566850 0050509399

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 6.0X14X150CM EXPRESS SD BILIARY STENT SYSTEM