BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 2973822 · Received February 22, 2013

    Report

    Report Number
    9616099-2013-00081
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    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

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES: GW: RADIFOCUS; BC: MAXILD 20/40 MM; STENT: ZENITH.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT A MAXI-LD (20/40MM) BALLOON RUPTURED BEFORE IT WAS EXPANDED TO 20 MM DURING SECOND POST-DILATION OF A STENT PLACED FOR GRAFTING OF AN AAA (ABDOMINAL AORTIC ARTERY). THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THE LESION WAS DE NOVO, BUT DESCRIBED AS UN-CALCIFIED, SLIGHTLY TORTUOUS, WITH PERCENT OF STENOSIS UNKNOWN. A STENT GRAFT (ZENITH) WAS PLACED IN THE TARGET LESION AND MAXI-LD (20/40MM 110CM: COMPLAINT PRODUCT) WAS DELIVERED INSIDE THE STENT GRAFT FOR POST-DILATION. DILATION WAS CONDUCTED WITHOUT ISSUES AT THE FIRST INFLATION, BUT THE BALLOON RUPTURED AT THE SECOND DILATION BEFORE THE BALLOON WAS EXPANDED TO 20MM. INFLATION PRESSURE IS UNKNOWN BECAUSE THE BALLOON WAS INFLATED WITHOUT AN INDEFLATOR. THE MAXI-LD WAS RETRIEVED FROM THE PATIENT AND A NEW MAXI-LD (SAME SIZE) WAS USED INSTEAD. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEMS. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. 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. WITHOUT THE RETURN OF THE PRODUCT THE REPORTED CUSTOMER COMPLAINT OF BALLOON BURST COULD NOT BE CONFIRMED. WITH THE LIMITED INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED EVENT. CONTROLS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM BEING DISTRIBUTED AND THE DEVICE HISTORY REPORT REVIEW INDICATED THAT THERE WERE NO ISSUES ASSOCIATED WITH THE REPORTED COMPLAINT. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE REPORTED INFORMATION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING USE OF A MAXI-LD (20/40 MM) BALLOON, THE BALLOON RUPTURED AT THE SECOND DILATION BEFORE THE BALLOON WAS EXPANDED TO 20 MM. THE PATIENT WAS A MALE, BUT AGE WAS UNKNOWN. THE PROCEDURE WAS A STENT GRAFTING FOR AAA (ABDOMINAL AORTIC ARTERY). IT IS UNKNOWN IF THE LESION WAS DE NOVO, BUT WAS SLIGHTLY TORTUOUS. THERE WAS NO CALCIFICATION. THE PERCENT OF THE STENOSIS WAS UNKNOWN. A STENT GRAFT (ZENITH) WAS PLACED IN THE TARGET LESION AND MAXI-LD (20/40 MM 110 CM: COMPLAINT PRODUCT) WAS DELIVERED INSIDE THE STENT GRAFT FOR POST-DILATION. DILATION WAS CONDUCTED WITHOUT ISSUES AT THE FIRST INFLATION, BUT THE BALLOON RUPTURED AT THE SECOND DILATION BEFORE THE BALLOON WAS EXPANDED TO 20 MM. (INFLATION PRESSURE UNKNOWN, BECAUSE THE BALLOON WAS INFLATED WITHOUT AN INDEFLATOR). THE MAXI-LD WAS RETRIEVED FROM THE PATIENT AND A NEW MAXI-LD (SAME SIZE) WAS USED INSTEAD. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77812 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS DE MEXICO NA 15652860

    Patients

    Seq Age Sex Outcome Treatment
    1