BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA STAR RX PTCA BALLOON CATHETER

    MDR report key: 1912107 · Received December 1, 2010

    Report

    Report Number
    9616099-2010-00903
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S89
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, WHILE IN THE PATIENT THE SAKURA DURA STAR, 3.00 X 15 BALLOON INFLATED UP TO 4-6 ATMOSPHERES AND FAILED TO INFLATE ANY FURTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME LIKE PRODUCT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND PRELIMINARY ANALYSIS SHOWED THAT A PINHOLE WAS NOTED AT 31CM FROM THE DISTAL END OF THE SHAFT. (B)(4): ONE NON STERILE SAKURA DURA STAR, 3.00 X 15 PTCA BALLOON CATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. TWO KINKS WERE FOUND AT 14.9 CM AND 18.3 CM BOTH FROM DISTAL END; THIS CONDITION CAN BE RELATED TO THE WAY THE UNIT WAS SENT FOR ANALYSIS. RESIDUES OF CRYSTALLIZED INFLATION MEDIUM WERE OBSERVED IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS RECEIVED ALREADY INFLATED AND DEFLATED. BLOOD RESIDUES WERE OBSERVED IN THE BALLOON. THE SHAFT WAS FOUND TORN AT 32.3 CM FROM DISTAL END. AS AN ATTEMPT TO INFLATE THE BALLOON THE SHAFT WAS CUT FROM THE DAMAGED AREA, THE CRYSTALLIZED RESIDUES WERE REMOVED AND THE BALLOON COULD BE INFLATED WITH PRESSURIZED WATER AT 14 ATM (RATED BURST PRESSURE). SEM ANALYSIS RESULTS: SHOWED THAT THE SHAFT EXTERNAL AND INTERNAL SURFACES EXHIBITED EVIDENCE OF ABRASIONS NEXT TO THE DAMAGED AREA. THE INNER BODY EXHIBITED EVIDENCE OF MULTIPLE ABRASIONS ON ITS EXTERNAL SURFACE. THE EXACT CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED BALLOON/ INFLATION DIFFICULTY-PARTIAL OR SLOW WERE NOT CONFIRMED SINCE THE RESIDUES WERE REMOVED AND THE UNIT COULD BE INFLATED WITHIN SPECIFICATION TIME. THE REPORTED BODY/SHAFT/ PUNCTURE/CUT WAS CONFIRMED, HOWEVER THE EXACT CAUSE OF FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE CONFIRMED FAILURE, NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURES ARE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE ORIGINAL INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, WHILE IN THE PATIENT THE SAKURA DURA STAR, 3.00 X 15 BALLOON INFLATED UP TO 4-6 ATMOSPHERES AND FAILED TO INFLATE ANY FURTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME LIKE PRODUCT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND PRELIMINARY ANALYSIS SHOWED THAT A PINHOLE WAS NOTED AT 31CM FROM THE DISTAL END OF THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 15158635

    Patients

    Seq Age Sex Outcome Treatment
    1