BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1901255 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05304
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE RETURNED PRODUCT CONSISTED OF AN OVER-THE-WIRE (OTW) STERLING ES BALLOON CATHETER WITH AN UNIDENTIFIED GUIDE WIRE IN THE LUMEN OF THE CATHETER. THE GUIDE WIRE WAS PROTRUDING 158.5 CM FROM THE HUB AND WAS NOT THROUGH THE DISTAL END. THE OUTER DIAMETER (OD) OF THE GUIDE WIRE WAS MEASURED WITH A CALIBRATED LASER MICROMETER; THE OD WAS CONSISTENT WITH A .014" GUIDE WIRE. THE GUIDE WIRE COULD NOT BE REMOVED FROM THE CATHETER. THE OUTER SHAFT WAS SEPARATED 134 CM AND THE INNER SHAFT WAS SEPARATED 141 CM FROM THE HUB; THE SEPARATED DISTAL PORTION, INCLUDING THE BALLOON AND DISTAL TIP, WAS NOT RETURNED FOR ANALYSIS. THE SHAFT WAS BUCKLED NEAR THE STRAIN RELIEF AND 113-134 CM FROM THE HUB. THE SHAFT APPEARED TO BE STRETCHED, CONSISTENT WITH TENSILE DEFORMATION. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE CONFIRMED DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LOCATION OF THE SEPARATED DISTAL PORTION OF THE DEVICE IS UNKNOWN. THE PATIENT'S RIGHT "CRURAL" BLOOD CIRCULATION WAS INADEQUATE AND THE PATIENT HAD A SEVERELY ISCHEMIC LIMB. MORE THAN 9 DAYS FOLLOWING THIS PROCEDURE, A BELOW-THE-KNEE AMPUTATION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE AND REMOVAL DIFFICULTIES OCCURRED. THE 90% RE-STENOSED LESION WAS LOCATED IN PREVIOUSLY PLACED NON-BSC STENTS LOCATED IN THE RIGHT COMMON ILIAC ARTERY (CIA) TO THE EXTERNAL ILIAC ARTERY (EIA). THE STENTS WERE 8 X 120MM AND 8 X 60MM, AND WERE NOT OVERLAPPED. THE VESSEL WAS SEVERELY CALCIFIED WITH MODERATE TORTUOSITY, AND THE LESION WAS APPROXIMATELY 10MM IN LENGTH. THE LESION HAD A SIGNIFICANT BEND OF ABOUT 45 DEGREES. FOLLOWING ACCESS BEING GAINED ON THE LEFT SIDE, A NON-BSC GUIDE WIRE CROSSED THE LESION. THE STERLING ES OTW 4 X 40MM BALLOON CATHETER WAS ADVANCED, AND THREE SUCCESSFUL INFLATIONS WERE PERFORMED. ON THE FOURTH INFLATION TO 6 ATMS, THE BALLOON RUPTURED. SEVERE RESISTANCE WAS NOTED DURING REMOVAL OF THE BALLOON FROM THE STENT, NOTING TO BE RELATED TO A STRUT OF THE STENT. HOWEVER, THE DEVICE WAS REMOVED WITH FORCE WITHOUT ANY ADDITIONAL INTERVENTION. THE STERLING ES BALLOON WAS NOTED TO BE DAMAGED AND ELONGATED UPON REMOVAL. ANGIOGRAPHY WAS PERFORMED, AND NO DEVICE FRAGMENTS WERE FOUND NOTED TO HAVE REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134404010 13013374

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other TERUMO 4F RADIFOCUS INTRODUCER SHEATH| JOHNSON AND JOHNSON DEJAVE GUIDE WIRE| ENCORE INFLATION DEVICE