BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 2962181 · Received February 14, 2013

    Report

    Report Number
    9616099-2013-00069
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    KNQ
    PMA / PMN Number
    K023907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS INDICATED BY THE AFFILIATE, DURING PREP FOR A TRANSAORTIC VALVE REPLACEMENT (TAVR), THE MAXI LD 110 CM. 7 FR. 25 X 4 BALLOON CATHETER WAS NOTED TO HAVE A HOLE IN IT DURING INFLATION/POSITIVE PRESSURE OUTSIDE THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. NEGATIVE PREP WAS PERFORMED USING A SYRINGE TO REMOVE AIR FROM THE SYSTEM. A SMALL PIN-HOLE LEAK WAS DETECTED DURING THE POSITIVE PREP WHICH WAS PERFORMED TO ASSESS THE APPROPRIATE BALLOON SIZE FOR USE WITH AN EDWARDS VALVE. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. (B)(4): ONE NON STERILE CATHETER MAXI LD 7F 25MM X 4.0CM 110.0CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN INFLATED. THE INFLATION MEDIUM RESIDUES WERE OBSERVED IN THE RETURNED DEVICE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. AN ATTEMPT TO INFLATE THE BALLOON WAS DONE AND DURING INFLATION IT WAS NOTED THE BALLOON LEAKING DUE TO A PIN HOLE AT 7.8CM FROM THE DISTAL TIP END. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BALLOON LEAKAGE. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHING; THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. 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 'LEAKAGE - DURING POSITIVE PRESSURE' FAILURE WAS CONFIRMED THROUGH ANALYSIS. THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED; HOWEVER SINCE NO ANOMALIES WERE DETECTED DURING NEGATIVE PREP AND SCRATCHES WERE NOTED ON THE BALLOON DURING ANALYSIS, THERE ARE POSSIBLE HANDLING FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT WHILE PREPARING FOR A TRANSAORTIC VALVE REPLACEMENT/TAVR, THE 110 CM 7 FR MAXI LD 25 X 4 BALLOON CATHETER WAS NOTED TO HAVE A HOLE IN IT DURING INFLATION/POSITIVE PRESSURE OUTSIDE THE PATIENT. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE/IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65964 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS DE MEXICO NA 15521248

    Patients

    Seq Age Sex Outcome Treatment
    1