BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿ SL

    MDR report key: 2980531 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01667
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K093720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER: CORRECTED FROM 'UNKNOWN' TO 15219137. DEVICE EXPIRATION DATE: CORRECTED FROM 'UNKNOWN' TO 05/02/2014. DEVICE MANUFACTURED DATE: CORRECTED FROM 'UNKNOWN' TO 05/04/2012. DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE CATHETER WAS RECEIVED WITH A GUIDE WIRE STUCK INSIDE THE WIRE LUMEN AND 206CM PROTRUDING FROM THE CATHETER HUB. SOLIDIFIED BLOOD AND CONTRAST WERE NOTED IN THE BALLOON AND INFLATION LUMENS. THE TIP WAS DAMAGED. THE INNER SHAFT WAS BUCKLED ON BOTH SIDES OF THE PROXIMAL MARKERBAND. THERE WAS A HOLE IN THE INNER SHAFT ADJACENT TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE CATHETER WAS SOAKED IN WATER, BUT THE GUIDE WIRE COULD NOT BE REMOVED. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR THE 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-00958, 2134265-2013-00959. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE GUIDE WIRE PENETRATED THE BALLOON LUMEN AND A BALLOON RUPTURE OCCURRED. THE PATIENT WAS UNDERGOING TREATMENT FOR DIABETES MELLITUS OF THE RIGHT FOOT. THE APPROXIMATELY 80% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY (ATA). A V-18 CONTROL WIRE WAS ADVANCED TO THE LESION AND A 2.5 X 150 MM STERLING SL BALLOON CATHETER WAS ADVANCED OVER THE WIRE. WHILE ATTEMPTING TO ACCESS THE TRUE LUMEN OF THE RIGHT ATA, THE V-18 WIRE PENETRATED THE BALLOON LUMEN OF THE STERLING. THE GUIDE WIRE AND BALLOON WERE EXCHANGED FOR IDENTICAL DEVICES. THE SECOND 2.5 X 150 MM STERLING SL BALLOON RUPTURED AT RATED BURST PRESSURE ON THE SECOND INFLATION ATTEMPT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-00958, 2134265-2013-00959. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE GUIDE WIRE PENETRATED THE BALLOON LUMEN AND A BALLOON RUPTURE OCCURRED. THE PATIENT WAS UNDERGOING TREATMENT FOR DIABETES MELLITUS OF THE RIGHT FOOT. THE APPROXIMATELY 80% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY (ATA). A V-18 CONTROL WIRE WAS ADVANCED TO THE LESION AND A 2.5X150MM STERLING SL BALLOON CATHETER WAS ADVANCED OVER THE WIRE. WHILE ATTEMPTING TO ACCESS THE TRUE LUMEN OF THE RIGHT ATA, THE V-18 WIRE PENETRATED THE BALLOON LUMEN OF THE STERLING. THE GUIDE WIRE AND BALLOON WERE EXCHANGED FOR IDENTICAL DEVICES. THE SECOND 2.5X150MM STERLING SL BALLOON RUPTURED AT RATED BURST PRESSURE ON THE SECOND INFLATION ATTEMPT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84287 STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939148251590 15219137

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR