BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM PTA DILATATION CATHETER

    MDR report key: 2371906 · Received December 14, 2011

    Report

    Report Number
    9616099-2011-00935
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 29, 2011
    Report Date
    November 29, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K003159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION RECEIVED FROM THE FIELD STATES THAT THE SLALOM THRILL BALLOON RUPTURED AT APPROXIMATELY 12ATM USING AN ENCORE26 INDEFLATOR (BSJ). THE PATIENT WAS MALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS ANTEBRACHIAL VEIN. NO CALCIFICATION AND THE RATE OF STENOSIS WAS 90%, VESSEL TORTUOSITY WAS UNKNOWN. APPROACH WAS MADE FROM THE VEIN SIDE WITH 4F SHEATH INTRODUCER (MEDIKIT). THE TARGET LESION WAS CROSSED WITH 0.018 KYOUSHA GUIDEWIRE (100MM, BSJ), SLALOM THRILL (COMPLAINT PRODUCT) WAS DELIVERED. HOWEVER THE BALLOON RUPTURED USING AN ENCORE26 INDEFLATOR (BSJ). THE BRAND OF CONTRAST USED IN THE PROCEDURE IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN. THE DEVICE WAS CHANGED TO ANOTHER PRODUCT ((B)(4), LOT UNK) AND THE PROCEDURE WAS COMPLETED WITHOUT OTHER PROBLEM. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. 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 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. CONCOMITANT DEVICES: 4F SHEATH INTRODUCER (MEDIKIT), .018 KYOUSHA GUIDEWIRE (100MM, BSJ), ENCORE26 INDEFLATOR (BSJ).

    Additional Manufacturer Narrative · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO THE ANTEBRACHIAL VEIN THE BALLOON WAS REPORTED TO HAVE RUPTURED AT 12 ATMOSPHERES. THE VESSEL WAS DESCRIBED AS HAVING NO CALCIFICATION WITH A 90% STENOSIS. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE SLALOM THRILL 6X2 40CM 4F WAS RECEIVED COILED INSIDE A PLASTIC BAG. BALLOON APPEARED AS IF IT HAS BEEN PREVIOUSLY INFLATED. NO DAMAGES WERE NOTED ALONG THE UNIT. LEAK TEST REQUIRED WAS PERFORMED AND A BURST WAS FOUND IN THE PROXIMAL SECTION OF THE BALLOON. ANALYSIS 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. THE PROXIMAL MARKER BAND EXHIBITED NO ANOMALIES. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. FAILURE REPORTED BY THE CUSTOMER AS BALLOON BURST AT BELOW RBP WAS CONFIRMED, THE EXACT CAUSE OF THE FAILURE REPORTED COULD NOT BE CONCLUSIVELY DETERMINED, CONTROLS ARE PLACED TO PREVENT DEFECTIVE UNITS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT THE BALLOON OF THE PALMAZ GENESIS RUPTURED DURING STENT PLACEMENT CAUSING THE STENT TO BE PLACED DISTAL TO THE TARGET LESION. THE PATIENT WAS MALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS RENAL ARTERY. HEAVY CALCIFICATION AND MODERATE VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 80%. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE PALMAZ GENESIS ((B)(4)/ LOT 15383340) WAS DELIVERED TO THE TARGET LESION BUT THE BALLOON RUPTURED AT THE BELOW NOMINAL PRESSURE. THE CONTRAST USED IN THE PROCEDURE IS UNKNOWN. THE CONTRAST TO SALINE RATIO USED TO INFLATE THE BALLOON IS UNKNOWN. IT IS UNKNOWN IF THERE ANY DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE OR TRACKING THE SDS TO THE LESION. THE STENT WAS DEPLOYED AND THERE WAS GOOD WALL APPOSITION AFTER DEPLOYMENT. THE STENT WAS MANAGED TO BE DILATED BUT IT WAS PLACED DISTAL TO THE TARGET LESION. THEREFORE, AN ADDITIONAL STENT (DETAILS UNKNOWN) WAS PLACED PROXIMAL TO THE FIRST STENT AND THE ENTIRE LESION WAS FULLY COVERED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15156144

    Patients

    Seq Age Sex Outcome Treatment
    1