BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1950713 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05900
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 24, 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)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STERLING ES OVER-THE-WIRE (OTW) DEVICE WAS RECEIVED WITH NO OTHER DEVICES OR ORIGINAL PACKAGING. VISUAL AND MICROSCOPIC ANALYSIS REVEALED DRIED BLOOD AND CONTRAST WERE VISIBLE IN THE BALLOON AND INFLATION LUMEN. THE BALLOON WAS IN A DEFLATED STATE. THERE WAS A PINHOLE AND SCRATCHES LOCATED ON THE DISTAL SIDE OF THE MARKERBAND. MICROSCOPIC INSPECTION OF THE BALLOON MATERIAL AND THE REMAINDER OF THE DEVICE REVEALED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE PINHOLE AND SCRATCHES IN THE OUTER SURFACE OF THE BALLOON ARE CONSISTENT WITH THE REPORTED BURST. 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)DEVICE EVALUATED BY MANUFACTURER:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS 100% STENOSED AND LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED ANTERIOR TIBIAL ARTERY (ATA). A 1.5MM X 20MM X 142CM STERLING ES PTA BALLOON CATHETER WAS ADVANCED AND ON THE FIRST INFLATION TO 8ATMS, A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION WAS DE NOVO. THE BALLOON CATHETER WAS SELECTED FOR PRE DILATION AND DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED. THE BALLOON RUPTURE OCCURRED AT THE SAME TIME AS THE BALLOON INFLATION. THE BALLOON CATHETER WAS FULLY DEFLATED AND ABLE TO BE REMOVED INTACT. THE PRE DILATION PROCEDURE WAS NOT PERFORMED; HOWEVER THE LESION WAS POST DILATED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION WAS DE NOVO. THE BALLOON CATHETER WAS SELECTED FOR PRE DILATION AND DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED. THE BALLOON RUPTURE OCCURRED AT THE SAME TIME AS THE BALLOON INFLATION. THE BALLOON CATHETER WAS FULLY DEFLATED AND ABLE TO BE REMOVED INTACT. THE PRE DILATION PROCEDURE WAS NOT PERFORMED; HOWEVER THE LESION WAS POST DILATED.

    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 H74939134152010 13764046

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, ASATO XS 0.014 IN X 175 CM| GUIDE WIRE, EXTENSION| GUIDE WIRE, CRUISE 0.014 IN X 175 CM| INFLATION DEVICE, GOODMAN