BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 3070704 · Received April 22, 2013

    Report

    Report Number
    9616099-2013-00242
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE OF AN AVIATOR PLUS BALLOON, THE PHYSICIAN EXPERIENCED INFLATION AND DEFLATION DIFFICULTY AFTER SEVERAL DILATIONS WERE CONDUCTED AT LOW PRESSURE. THE TARGET LESION WAS THE RENAL ARTERY WHICH WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS AND STENOSIS WAS 90%. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE WITH A SHEATH. THE LESION WAS CROSSED WITH A GUIDEWIRE. AN AVIATOR PLUS BALLOON (5.0/20MM) WAS DELIVERED TO THE LESION FOR PRE-DILATION. THE PHYSICIAN INFLATED THE BALLOON SEVERAL TIMES AT 3 TO 4 ATMOSPHERES WITH AN ENCORE26 INDEFLATOR. WHEN THE PHYSICIAN ATTEMPTED TO INCREASE THE PRESSURE TO 8 ATMOSPHERES, THE PRESSURE WOULD NOT INCREASE AND IT TOOK A LONG TIME TO DEFLATE THE BALLOON. THE BALLOON WAS DEFLATED WHEN REMOVED FROM THE PATIENT. THEREFORE, THE PHYSICIAN STOPPED USING THE AVIATOR PLUS BALLOON AND A DIFFERENT BALLOON CATHETER WAS USED WITH THE SAME INDEFLATOR. THE PROCEDURE WAS FINISHED SUCCESSFULLY. AFTER THE PROCEDURE, THE PRODUCT WAS TESTED WITH INFLATION AND DEFLATION OUTSIDE THE PATIENT, AND THE PHYSICIAN FELT THAT THE BALLOON DID NOT INFLATE AND DEFLATE AS USUAL. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE BRAND OF CONTRAST USED IN THE PROCEDURE IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS NOT 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 RETURN OF THE DEVICE THE REPORTED ¿INFLATION DIFFICULTY-PARTIAL OR SLOW¿ AND ¿DEFLATION DIFFICULTY-PARTIAL OR SLOW¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (MODERATELY CALCIFIED AND MODERATELY TORTUOUS AND STENOSIS WAS 90%) AND PROCEDURAL FACTORS (RADIAL APPROACH) MAY HAVE CONTRIBUTED TO THE DIFFICULTY REPORTED BY THE CUSTOMER. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE DIFFICULTY REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION 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. CONCOMITANT DEVICES: INFLATION DEVICE: ENCORE26, GW: RUNTHROUGH, YCONNECTOR: GOODMAN'S, STENT: GENESIS 6.0/18MM 2PCS.

    Description of Event or Problem · 1

    DURING USE OF AN AVIATOR PLUS BALLOON, THE PHYSICIAN EXPERIENCED INFLATION AND DEFLATION DIFFICULTY AFTER SEVERAL DILATIONS WERE CONDUCTED AT LOW PRESSURE. AFTER SLOWLY DEFLATING THE BALLOON IT WAS REMOVED AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS THE RENAL ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, AND MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE % OF THE STENOSIS WAS 90%. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE WITH A SHEATH (JR). THE LESION WAS CROSSED WITH A GUIDEWIRE (RUNTHROUGH). AN AVIATOR PLUS BALLOON (5.0/20MM) WAS DELIVERED TO THE LESION FOR PRE-DILATION. THE PHYSICIAN INFLATED THE BALLOON SEVERAL TIMES WITH 3 TO 4 ATMOSPHERES (ATM) OF PRESSURE WITH AN INDEFLATOR (ENCORE26). WHEN THE PHYSICIAN ATTEMPTED TO INCREASE THE PRESSURE TO 8ATM, THE PRESSURE WOULD NOT INCREASE AND IT TOOK A LONG TIME TO DEFLATE THE BALLOON. THE BALLOON WAS DEFLATED WHEN REMOVED FROM THE PATIENT. THEREFORE, THE PHYSICIAN STOPPED USING THE AVIATOR PLUS BALLOON AND A DIFFERENT BALLOON CATHETER (NOT SPECIFIED) WAS USED INSTEAD WITH THE SAME INDEFLATOR. THE PROCEDURE WAS FINISHED SUCCESSFULLY. AFTER THE PROCEDURE, THE PRODUCT WAS TESTED WITH INFLATION AND DEFLATION OUTSIDE THE PATIENT, AND THE PHYSICIAN FELT THAT THE BALLOON WAS NOT INFLATED OR DEFLATED AS USUAL. THE BRAND OF CONTRAST USED IN THE PROCEDURE IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171663 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15618512

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR