BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 1813336 · Received August 24, 2010

    Report

    Report Number
    9610978-2010-00163
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 1, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ONE NON STERILE MAXI LD 7F 20 MM X 4CM AND 110CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED. NO DRY BLOOD RESIDUES WERE OBSERVED IN THE BALLOON AND CATHETER SHAFT. AN ATTEMPT TO INFLATE THE BALLOON WAS MADE. THE BALLOON COULD NOT BE INFLATED. A LEAKAGE WAS OBSERVED IN THE BALLOON DISTAL SIDE. A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT, RESULTS SHOWED THAT THE BALLOON EXHIBITED EVIDENCE OF EXTERNAL ABRASIONS/SCRATCHES NEXT TO THE LEAK-HOLE; THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE ABRASION COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BAND PRESENTED NO ANOMALIES. 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 COMPLAINT OF BALLOON LEAKAGE DURING NEGATIVE PREPARATION WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. NO ADDITIONAL PATIENT, LESION/VESSEL OR PROCEDURAL INFORMATION HAS BEEN PROVIDED. AT THIS TIME THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    MAXI-LD BALLOON CATHETER (COMPLAINT PRODUCT) WAS INTENDED TO BE USED FOR POST-DILATATION AFTER PLACING A STENT GRAFT (ZENITH, COOK) IN THE TARGET LESION. WHILE PURGING AIR FROM THE BALLOON AT THE PREPARATION, PIN-HOLE RUPTURED WAS SUSPECTED. THE MAXI-LD WAS CHANGED TO OTHER NEW PRODUCT (DETAILS UNK) AND AAA (ABDOMINAL AORTIC ANEURYSM) WAS TREATED SUCCESSFULLY. THE COMPLAINT PRODUCT WAS NOT CLINICALLY USED. THERE WILL BE PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS EUROPA, N.V. NA R0209194

    Patients

    Seq Age Sex Outcome Treatment
    1