BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1896926 · Received November 11, 2010

    Report

    Report Number
    2134265-2010-05284
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). RETURNED PRODUCT CONSISTED OF A MONORAIL (MR) STERLING ES BALLOON CATHETER WITH DRIED BLOOD IN THE SHAFT. VISUAL AND TACTILE INSPECTION OF THE SHAFT REVEALED A SEPARATION LOCATED APPROXIMATELY 25 CM FROM THE TIP (DISTAL END). EXAMINATION OF THE MATERIAL SURROUNDING THE SEPARATION AND DAMAGE DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. THERE WERE KINKS APPROXIMATELY 24.5 AND 25 CM FROM THE TIP AND 119 AND 119.5 CM FROM THE HUB. MICROSCOPIC INSPECTION 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT KINK OCCURRED. ACCESS WAS GAINED WITH A 4.5F NON-BSC SHEATH INSERTED IPSILATERALLY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT POSTERIOR TIBIAL ARTERY. A 1.5X20MMX143CM STERLING ES MONORAIL BALLOON CATHETER WAS ADVANCED OVER A NON-BSC GUIDE WIRE. HOWEVER, A SHAFT KINK 2CM FROM THE GUIDE WIRE LUMEN WAS OBSERVED, SO THE DEVICE WAS EXCHANGED FOR A NON BSC BALLOON CATHETER, WHICH WAS UNABLE TO CROSS THE LESION AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, PRODUCT ANALYSIS REVEALED A SHAFT BREAK.

    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 H74939135152010 12918966

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO PERIPHERAL GUIDE WIRE| MEDIKIT PARENT 4.5F SHEATH