BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGER?

    MDR report key: 3843939 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-02998
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K112697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR: RECEIVED FOR ANALYSIS WAS THE CHARGER BALLOON CATHETER ALONG WITH A GUIDEWIRE AND GUIDE CATHETER. AN EXAMINATION OF THE BALLOON CATHETER IDENTIFIED THAT A BREAK OCCURRED IN THE SHAFT AT THE LAPWELD SITE. A COMPLETE BALLOON CIRCUMFERENTIAL TEAR WAS PRESENT IN THE PROXIMAL TRANSITION OF THE BALLOON. THE DISTAL SECTION OF THE BALLOON TEAR WAS NOT RECEIVED FOR ANALYSIS. A STRETCHED SECTION OF THE BALLOON CATHETER WITH A MARKERBAND ATTACHED WAS RECEIVED. THIS SECTION MEASURED APPROXIMATELY 14.6CM. AN EXAMINATION OF THE GUIDE CATHETER IDENTIFIED THAT THE GUIDE WAS KINKED AT 26.5CM PROXIMAL FROM THE TIP. THE GUIDE CATHETER WAS CHECKED TO SEE IF THE MISSING SECTION OF THE BALLOON WAS PRESENT INSIDE HOWEVER, NO TRACES OF THE BALLOON WERE FOUND. THE OUTER DIAMETER OF THE WIRE WAS MEASURED AND NO ISSUES WERE NOTED WITH THE GUIDEWIRE. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON DETACHMENT AND BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIAC ARTERY. A 7.0 X100, 135CM CHARGER BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. FIRST INFLATION WAS AT 4 ATMOSPHERES AND SECOND INFLATION WAS AT 6 ATMOSPHERES. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. WHEN THEY TRIED TO PULL THE BALLOON OUT OF THE SHEATH, IT WAS NOTED THAT THE BALLOON WAS SEPARATED FROM THE SHAFT. EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY. ANGIOGRAPHY WAS THEN PERFORMED WHICH SHOWED THAT THE ARM AND THE VESSEL WAS PATENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON DETACHMENT AND BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIAC ARTERY. A 7.0 X100, 135CM CHARGER¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. FIRST INFLATION WAS AT 4 ATMOSPHERES AND SECOND INFLATION WAS AT 6 ATMOSPHERES. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. WHEN THEY TRIED TO PULL THE BALLOON OUT OF THE SHEATH, IT WAS NOTED THAT THE BALLOON WAS SEPARATED FROM THE SHAFT. EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY. ANGIOGRAPHY WAS THEN PERFORMED WHICH SHOWED THAT THE ARM AND THE VESSEL WAS PATENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321202 CHARGER? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206071010 0016769899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other