BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 1872859 · Received October 18, 2010

    Report

    Report Number
    9610978-2010-00206
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE POUCH FOR A PTA SAVVY 4.0MMX4CM, 80CM WAS RECEIVED INSIDE OF ANOTHER POUCH. THE POUCH PRESENTED EVIDENCE THAT IT HAD BEEN OPENED AT THE CHEVRON SEALING SIDE; THE INNER LABEL MATCHED THE REPORTED LOT. IN ADDITION, FOLDED SURGICAL GAUZE AND LOOSE PARTICLES OF THE GAUZE WERE NOTED INSIDE OF THE PRODUCT'S POUCH. THE GAUZE WAS MEASURED AND IT HAS THE FOLLOWING VALUES: FOLDED 9CMX10CM AND EXPANDED 38CMX39CM. NO PRODUCT WAS RETURNED WITH THE POUCH. 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 FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE EXACT CAUSE OF THE FOREIGN PARTICLES INSIDE OF THE OPENED POUCH COULD NOT BE CONCLUSIVELY DETERMINED. A 100% VISUAL INSPECTION IS IN PLACE TO INSPECT FOR ANY CONTAMINATION OF THE INNER POUCH BEFORE THE PRODUCT LEAVES THE FACILITY. LOOSE PARTICLES ARE NOT ACCEPTABLE IN THE POUCH. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IT IS LIKELY THAT THE PIECE OF GAUZE WAS INSERTED AT THE POINT OF USE AS THIS MATERIAL WOULD NOT BE PRESENT AT THE POINT OF MANUFACTURE.

    Description of Event or Problem · 1

    ON OPENING THE PTA SAVVY 4.0MM/4.0CM 80CM BALLOON THERE SEEMS TO BE A FEW FOREIGN BIT`S INSIDE PACKAGE. THE TECH DID NOT NOTICE ANY DAMAGE TO THE OUTER BOX OR POUCH PRIOR TO OPENING. THE POUCH SEAL WAS INTACT. THE PIECE OF WHITE PAPER / CARDBOARD WAS VERY NARROW AND THE IMPRESSION OF THE REPORTER IS THAT IT COULD HAVE BEEN A PIECE OF THE CARD WHICH THE BALLOON WAS PACKED ON INSIDE THE POUCH. IT LOOKED LIKE A "SLIVER" OF CARD WHICH HAD NOT BEEN SEPARATED PROPERLY FROM THE MAIN PIECE OF CARD WHEN A SLOT WAS CUT IN THE CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15150677

    Patients

    Seq Age Sex Outcome Treatment
    1