BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI PTA BALLOON CATHETER

    MDR report key: 2990063 · Received March 5, 2013

    Report

    Report Number
    9616099-2013-00127
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY AN AFFILIATE, DURING POST DILATION OF AN ATRIUM STENT IN THE LEFT ILIAC ARTERY, A MAXI LD BALLOON BURST LONGITUDINALLY WHEN INFLATED UP TO SIX ATMOSPHERES. WHEN REMOVING THE BALLOON CATHETER OVER THE GUIDEWIRE, THE SECONDARY PROFILE OF THE BALLOON WAS VERY BIG AND DID NOT FIT THROUGH THE NINE FRENCH SHEATH, WHICH CAUSED RADIAL TEARS OF THE BALLOON. A PIECE OF THE BALLOON SEPARATED WHEN PULLING THE BALLOON OUT OF THE VALVE OF THE SHEATH. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL OR OVER THE WIRE TO GET TO THE LESION. THE BALLOON WAS NOT USED PREVIOUSLY IN THE PROCEDURE AND BURST DURING ITS INITIAL INFLATION. THERE WAS NO EXCESSIVE FORCE USED TO WITHDRAW THE BALLOON. THE TARGET LESION WAS SUCCESSFULLY TREATED WITH THE COMPLAINT PRODUCT AND DID NOT REQUIRE FURTHER INTERVENTION. THERE WAS NO HARM TO THE PATIENT, NO RISK OF EMBOLIZATION OF BALLOON MATERIAL AND NO INJURY REPORTED. ONE NON STERILE MAXI LD 7F 15X4 80CM WAS RECEIVED COILED IN A PLASTIC BAG. THE DISTAL SECTION OF THE BALLOON WAS NOT RECEIVED WITH THE DEVICE. A LEAK TEST COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE BALLOON AND BODY SHAFT. INSERTION WITHDRAWAL TEST WAS NOT PERFORMED DUE TO THE DEVICE CONDITIONS. ANALYSIS RESULTS SHOWED THAT THE BALLOON EXTERNAL AND INTERNAL SURFACES EXHIBITED NO EVIDENCE OF DAMAGES. THE INNER BODY SEPARATION SURFACE PRESENTED EVIDENCE OF ELONGATIONS; ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER 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 "BALLOON - BURST AT/BELOW RBP" WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT; HOWEVER POST-DILATION OF A STENT MAY HAVE CONTRIBUTED TO THE BALLOON BURST. THE SECONDARY PROFILE OF THE BALLOON MAY HAVE CONTRIBUTED TO THE WITHDRAWAL DIFFICULTY AND SEPARATION OF THE BALLOON AS EVIDENCED BY ELONGATIONS AT THE POINT OF INNER BODY SEPARATION NOTED DURING ANALYSIS. NEITHER THE DHR, ANALYSIS, NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED BACK FOR ANALYSIS AND PRELIMINARY ANALYSIS SHOWS A 'BALLOON BURST, PARTAL BALLOON NOT INCLUDED.' ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A PIECE OF THE BALLOON SEPARATED WHEN PULLING THE BALLOON OUT OF THE VALVE OF THE ST. JUDE SHEATH. IT DID NOT SEPARATE IN THE PATIENT, BUT IT HAPPENED WHEN IT WAS WITHDRAWN THROUGH THE SHEATH NO INJURY REPORTED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING USE OF A MAXI LD BALLOON FOR POST-DILATATION OF AN ATRIUM STENT IN THE LEFT ILIAC ARTERY, THE BALLOON BURST LONGITUDINAL WHEN INFLATED UP TO 6ATM. WHEN REMOVING THE BALLOON CATHETER, THE SECONDARY PROFILE OF THE BALLOON WAS VERY BIG AND DID NOT FIT THROUGH THE 9F ST. JUDE SHEATH, WHICH CAUSED RADIAL TEARS OF THE BALLOON. NO INJURY REPORTED. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL OR OVER THE WIRE TO GET TO THE LESION. THE BALLOON WAS NOT USED PREVIOUSLY IN THE PROCEDURE AND BURST DURING ITS INITIAL INFLATION. THE BALLOON WAS PULLED THROUGH THE 9F ST. JUDE SHEATH OVER THE GUIDEWIRE, WHILE IT WAS STILL IN THE PATIENT WHICH CAUSED ANOTHER TEAR IN THE BALLOON. THERE WAS NO EXCESSIVE FORCE USED TO WITHDRAW THE BALLOON. THE BALLOON DID NOT SEPARATE IN THE PATIENT. THE TARGET LESION WAS SUCCESSFULLY TREATED WITH THE COMPLAINT PRODUCT. THERE WAS NO HARM TO THE PATIENT, NO RISK OF EMBOLIZATION OF BALLOON MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93130 MAXI PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15583176

    Patients

    Seq Age Sex Outcome Treatment
    1 9F ST. JUDE SHEATH