BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 3060936 · Received April 16, 2013

    Report

    Report Number
    9616099-2013-00229
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE AFFILIATE, DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY WITH A SAVVY BALLOON CATHETER, THE BALLOON WOULD NOT INFLATE AND A LITTLE CRACK WAS NOTED IN THE DEVICE. THE TARGET LESION WAS REPORTED TO BE CALCIFIED, NOT TORTUOUS, WITH 80% STENOSIS. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING/HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION OF THE DEVICE PRIOR TO INSERTION INTO THE PATIENT. THE PRODUCT WAS PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE RATIO OF CONTRAST TO SALINE WAS ONE TO ONE (1:1). THE BRAND OF CONTRAST WAS UNKNOWN. THE BRAND/TYPE OF INFLATION DEVICE WAS NOT KNOWN, BUT THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE, GUIDING CATHETER OR THE VASCULATURE. THERE WAS NO REPORTED DIFFICULTY ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE PRODUCT WAS REMOVED FROM THE PATIENT AND WAS INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER THE DETAILS WERE NOT REPORTED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS RETURNED FOR INSPECTION. (B)(4): ONE NON STERILE CATHETER PTA SAVVY 120CM 5X4 WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS PREVIOUSLY INFLATED. NO OTHER DAMAGES WERE NOTED. A LEAK TEST WAS PERFORMED AND A LEAK WAS NOTED IN THE SHAFT NEAR THE BALLOON. RESULTS SHOWED THAT THE PIN HOLE OBSERVED AT THE INFLATION LUMEN WAS PROBABLY INDUCED BY AN INTERNAL EFFORT LIKE EXCESSIVE INTERNAL PRESSURE. THE ELONGATIONS AND THE RUPTURE OBSERVED COULD BE EVIDENCE OF EXCESS PRESSURE. THERE IS NO EVIDENCE OF TOOL DAMAGE, ABRASIONS OR SCRATCHES THAT COULD BE ATTRIBUTABLE TO THE PIN HOLE IN THIS ANALYSIS. DURING THE MANUFACTURING PROCESS THE UNITS ARE 100% LEAK TESTED TO PREVENT DEFECTIVE UNITS FROM LEAVING THE BUILDING. 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 CUSTOMER COMPLAINT OF INFLATION DIFFICULTY DUE TO A ¿CRACK¿ IN THE DEVICE WAS CONFIRMED THROUGH FAILURE ANALYSIS, AS A PINHOLE WAS IDENTIFIED IN THE INFLATION LUMEN. RESULTS SHOWED THAT THE PIN HOLE OBSERVED AT THE INFLATION LUMEN WAS PROBABLY INDUCED BY AN INTERNAL EFFORT LIKE EXCESSIVE INTERNAL PRESSURE. THE ELONGATIONS AND THE RUPTURE OBSERVED COULD BE EVIDENCE OF EXCESS PRESSURE. SINCE THE BALLOON PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE, THERE IS NOTHING TO SUGGEST THAT THE ISSUE WAS PRESENT WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE EXACT CAUSE FOR THE ISSUE COULD NOT CONCLUSIVELY BE DETERMINED; HOWEVER AS THE DEVICES GO THROUGH 100% LEAK TEST PRIOR TO PREVENT DEFECTIVE UNITS FROM LEAVING THE BUILDING, THERE IS NO INDICATION THAT IT IS RELATED TO THE MANUFACTURING OF THE DEVICE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A LITTLE CRACK WAS NOTED ON THE 120 CM. SAVVY PTA 5 X 4 BALLOON CATHETER. THE PHYSICIAN NOTED THAT THE BALLOON WAS NOT INFLATED AFTER TRYING TO PUMP IT UP/INFLATE THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY-DETAILS NOT PROVIDED. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE SFA TARGET LESION WAS REPORTED TO BE: CALCIFIED, NOT TORTUOUS, NOT A CHRONIC TOTAL OCCLUSION (CTO), AND AN 80% STENOSIS. THERE WAS REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING/HOOP. THERE WAS NO REPORTED PROBLEM REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION OF THE DEVICE PRIOR TO INSERTION INTO THE PATIENT. THE PRODUCT WAS PREPPED NORMALLY/MAINTAINED NEGATIVE PRESSURE. THE RATIO OF CONTRAST TO SALINE WAS ONE TO ONE (1:1). THE BRAND OF CONTRAST WAS UNKNOWN. THE BRAND/TYPE OF INFLATION DEVICE WAS NOT KNOWN, BUT THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE, GUIDING CATHETER OR THE VESSEL/VASCULATURE. THERE WAS NO REPORTED DIFFICULTY ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE PRODUCT WAS REMOVED FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163641 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15718498

    Patients

    Seq Age Sex Outcome Treatment
    1