BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA¿

    MDR report key: 2212057 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03267
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 29, 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

    THE COMPLAINT DEVICE WAS RETURNED FOR VISUAL AND TACTILE EXAMINATION. ANALYSIS OF THE RETURNED DEVICE REVEALED NO DAMAGE TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED FULLY AROUND THE SHAFT OF THE DEVICE. THERE WAS CLEAR LIQUID PRESENT IN THE BALLOON. THE DEVICE WAS ATTACHED TO AN INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WHEN A LEAK WAS NOTED. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON OBSERVED A PINHOLE LOCATED APPROXIMATELY 4MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. 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 DILATION PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY. THE PHYSICIAN PRE-DILATED THE LESION AND THEN TRIED TO ADVANCE A NON-BSC STENT TO THE LESION BUT THE STENT DID NOT PASS THE LESION. THE PHYSICIAN THEN USED THE 5.0-20, 80 WANDA BALLOON WHICH RUPTURED AT 16 ATMS UPON THE 4TH INFLATION (1ST INFLATION: 12 ATM; 2ND INFLATION: 12 ATM; AND 3RD INFLATION: 16 ATM). THERE WAS NO EXTRA FORCE APPLIED TO THE DEVICE DURING ATTEMPTS TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND THE PROCEDURE WAS COMPLETED WITH AN EXPRESS LD STENT WITH NO ISSUES. 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 DILATION PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY. THE PHYSICIAN PRE-DILATED THE LESION AND THEN TRIED TO ADVANCE A NON-BSC STENT TO THE LESION BUT THE STENT DID NOT PASS THE LESION. THE PHYSICIAN THEN USED THE 5.0-20, 80 WANDA BALLOON WHICH RUPTURED AT 16ATMS UPON THE 4TH INFLATION (1ST INFLATION: 12ATM; 2ND INFLATION: 12ATM; AND 3RD INFLATION: 16ATM). THERE WAS NO EXTRA FORCE APPLIED TO THE DEVICE DURING ATTEMPTS TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND THE PROCEDURE WAS COMPLETED WITH AN EXPRESS LD STENT WITH NO ISSUES. 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¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505060 14136265

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: AMPLATZ 0.035INCH| INFLATION DEVICE: ENCORE| INTRODUCER SHEATH: TERUMO 6FR