BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 2103501 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-01958
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED FULLY AROUND THE SHAFT OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE WHEN A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE BALLOON OBSERVED TWO PINHOLES LOCATED ON THE DISTAL EDGE OF THE DISTAL MARKERBAND. NO DAMAGE WAS NOTED TO THE MARKERBANDS THAT MAY HAVE CONTRIBUTED TO THE BALLOON PINHOLES. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 99% STENOSED DIFFUSED LESION WAS 150MM IN LENGTH AND WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 3.0-20 WANDA BALLOON CATHETER WAS ADVANCED TO PRE DILATE BUT ENCOUNTERED DIFFICULTY CROSSING THE LESION. A NON BSC 014 GUIDE WIRE WAS ADVANCED AND SUCCESSFULLY CROSSED THE LESION. A 2-20 STERLING ES BALLOON CATHETER WAS ADVANCED AND SUCCESSFULLY INFLATED. THE NUMBER INFLATIONS AND ATMS IS UNKNOWN. A GUIDE WIRE EXCHANGE OCCURRED WITH A NON BSC 014 GUIDE WIRE WITH A 035 NON BSC GUIDE WIRE THAT SUCCESSFULLY CROSSED THE LESION. THE 3.0-20 WANDA BALLOON CATHETER WAS ADVANCED BUT DID NOT COMPLETELY CROSS THE LESION DUE TO VESSEL RECOIL. THE 3.0-20 BALLOON WAS INFLATED TWO TIMES TO 10 ATMS, AND ON THE A 3RD INFLATION TO 12 ATMS. DURING THE 4TH INFLATION TO 12 ATMS A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND AFTER, A 014 NON BSC GUIDE WIRE WAS ADVANCED AND SUCCESSFULLY CROSSED THE LESION. THE PROCEDURE WAS COMPLETED WITH A STERLING ES BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 99% STENOSED DIFFUSED LESION WAS 150MM IN LENGTH AND WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 3.0-20 WANDA BALLOON CATHETER WAS ADVANCED TO PRE DILATE BUT ENCOUNTERED DIFFICULTY CROSSING THE LESION. A NON BSC 014 GUIDE WIRE WAS ADVANCED AND SUCCESSFULLY CROSSED THE LESION. A 2-20 STERLING ES BALLOON CATHETER WAS ADVANCED AND SUCCESSFULLY INFLATED. THE NUMBER INFLATIONS AND ATMS IS UNKNOWN. A GUIDE WIRE EXCHANGE OCCURRED WITH A NON BSC 014 GUIDE WIRE WITH A 035 NON BSC GUIDE WIRE THAT SUCCESSFULLY CROSSED THE LESION. THE 3.0-20 WANDA BALLOON CATHETER WAS ADVANCED BUT DID NOT COMPLETELY CROSS THE LESION DUE TO VESSEL RECOIL. THE 3.0-20 BALLOON WAS INFLATED TWO TIMES TO 10 ATMS, AND ON THE A 3RD INFLATION TO 12 ATMS. DURING THE 4TH INFLATION TO 12 ATMS A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND AFTER, A 014 NON BSC GUIDE WIRE WAS ADVANCED AND SUCCESSFULLY CROSSED THE LESION. THE PROCEDURE WAS COMPLETED WITH A STERLING ES BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WANDA PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505240 13775949

    Patients

    Seq Age Sex Outcome Treatment
    1