BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL 3 X 2, 40CM

    MDR report key: 794740 · Received December 4, 2006

    Report

    Report Number
    9610978-2006-00522
    Event Type
    Malfunction
    Date Received
    December 4, 2006
    Date of Event
    November 8, 2006
    Report Date
    December 4, 2006
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT AVAILABLE FOR ANALYSIS. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MQP, INCLUDING BURST TEST VALUES. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY E7144602 WITH LOT NUMBER 0201060324. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE HAD AN IMPACT.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO A SHUNT ANASTOMOSIS THE BALLOON WAS REPORTED TO HAVE RUPTURED. THE VESSEL WAS DESCRIBED AS HAVING SEVERE CALCIFICATION, MILD TORTUOSITY AND AN UNKNOWN % STENOSIS. THE BALLOON WAS INFLATED USING AN INDEFLATOR; HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES DURING THE FIRST INFLATION. THE PRODUCT WAS PREPARED AND CLINICALLY USED AS PER THE IFU. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM THRILL 3 X 2, 40CM PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R0106355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN