BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA¿

    MDR report key: 2935880 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00194
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED IN SECTIONS ON THE GUIDEWIRE. THE SHAFT, DISTAL TO THE PROXIMAL MARKERBAND, WAS SEVERELY STRETCHED DOWN ONTO THE GUIDEWIRE. AN EXAMINATION OF THE DEVICE FOUND A COMPLETE BALLOON CIRCUMFERENTIAL TEAR AT THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. A BREAK OCCURRED IN THE SHAFT AT 5.5CM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. ANOTHER STRETCHED SECTION OF THE SHAFT MEASURING 4.2CM IN LENGTH WAS STRETCHED DOWN ONTO THE GUIDEWIRE. A THIRD SECTION OF THE SHAFT BREAK, INCLUDING THE DISTAL MARKERBAND WAS POSITIONED FURTHER DOWN ALONG THE GUIDEWIRE. THIS SECTION MEASURED 9.5CM IN LENGTH. 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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE WANDA BALLOON BROKE AND STAYED "STANTED" WITH A COMPETITOR GUIDE AFTER A TRANSLUMINAL ANGIOPLASTY ON A CALCIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. 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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE WANDA BALLOON BROKE AND STAYED "STANTED" WITH A COMPETITOR GUIDE AFTER A TRANSLUMINAL ANGIOPLASTY ON A CALCIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41470 WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505080 0015442219

    Patients

    Seq Age Sex Outcome Treatment
    1