BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 2223177 · Received August 25, 2011

    Report

    Report Number
    9616099-2011-00671
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE CATHETER PTA SAVVY 4.0 MM X 6.0 CM 120.0 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THERE WERE BLOOD RESIDUES NOTED IN THE CATHETER. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED. ONE AXIAL BALLOON BURST WAS NOTED. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. AN ATTEMPT TO INFLATE THE BALLOON WAS DONE PER (B)(4); HOWEVER AXIAL BURST WAS NOTED IN THE BALLOON AND DURING INFLATION A SECONDARY FAILURE WAS NOTED RELATED WITH LEAKAGE BETWEEN THE HUB'S PORTS. AS PART OF THE SECONDARY FAILURE'S INVESTIGATION FOR LEAKAGE IN THE HUB NOTED DURING FUNCTIONAL ANALYSIS; A CROSS SECTION WAS PERFORMED IN THE HUB'S INFLATION PORT SINCE DURING INFLATION SOME BUBBLES WERE NOTED FROM THE INNERBODY (BLUE TUBING), AFTER CROSS SECTION WAS COMPLETED A PUNCTURE WAS DETECTED IN THE INNER BODY. SEM ANALYSIS WAS PERFORMED IN ORDER TO IDENTIFY THE CAUSE OF BALLOON BURST. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASIONS NEAR THE TEAR-EDGE; THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE BURST COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BANDS EXHIBITED NO ANOMALIES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED THE FOLLOWING; (B)(4). THE BALLOON BURST REPORTED BY THE COSTUMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON BURST FAILURE COULD NOT BE DETERMINED, FOR THE SECONDARY FAILURE FOUND FOR LEAKAGE BETWEEN HUB'S PORTS THE EXACT CAUSE WAS ATTRIBUTED TO A PUNCTURE NOTED IN THE INNERBODY; HOWEVER THE ROOT CAUSE WAS NOT DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY (B)(4), NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURAL SETTING.

    Additional Manufacturer Narrative · 1

    THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED BURST. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE SECONDARY FAILURE FOR THE CATHETER BODY CONTAINING A PUNCTURE. PLEASE NOTE THAT THE SECOND DEVICE INVOLVED IN THIS PROCEDURE IS ASR REPORTABLE FOR BALLOON BURST UNDER MDR GUIDELINES AND WILL BE SUBMITTED UNDER THE ASR REPORT.

    Description of Event or Problem · 1

    THE BALLOON WAS REPORTED TO HAVE BURST IN A CALCIFIED RIGHT SFA LESION AT 4ATM. THE PHYSICIAN USED A 4 X 20MM SAVVY BALLOON TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO PATIENT INJURY REPORTED. ANALYSIS OF THE RETURNED PRODUCT CONFIRMED THE REPORTED BURST, AND A PUNCTURE WAS DETECTED IN THE INNER BODY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15075977

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR