BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 1812475 · Received August 24, 2010

    Report

    Report Number
    9610978-2010-00162
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: CONTRAST: VISIPAQUE 50:50 AND INDEFLATOR: BOSTON SCIENTIFIC ENCORE. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS AVAILABLE FOR TESTING AND EVALUATION BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS IT WAS REPORTED, THE FIRST AVIATOR BALLOON HAD A KINK NEAR THE BACK END OF THE SHAFT WHICH HAD A HOLE IN IT. A SECOND AVIATOR BALLOON HAD A KINK IN THE TIP OF THE BALLOON AND THE PHYSICIAN ENCOUNTERED DIFFICULTY TRACKING THE DEVICE TO THE LESION. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD AVIATOR BALLOON. THE KINK ON THE FIRST BALLOON WAS NOTICED WHEN THE TECH PULLED THE DEVICE FROM THE BACK TABLE TO HAND TO THE PHYSICIAN. IT WAS ALREADY OUT OF THE COIL TUBING AND PREPPED ON THE TABLE. AS FAR AS THE SALES REP COULD DETERMINE, THE DEVICE WAS HANDLED AND PREPPED PER IFU. THERE IS A CHANCE IT COULD HAVE BEEN KINKED BY THE TECH BUT WAS NOT NOTED BY THE SALES REP OR BY THE TECH. THE DEVICE WAS USED IN THE PATIENT TO TREAT A LESION IN THE LEFT INTERNAL CAROTID ARTERY WITH 95% STENOSIS. IT WAS IN PLACE IN THE LEFT INTERNAL CAROTID ARTERY AND WHEN THE TECH WENT TO INFLATE IT USING A BOSTON SCIENTIFIC ENCORE SHE NOTICED THE DYE SHOOTING OUT OF THE HOLE IN THE CATHETER WHERE IT WAS KINKED. THE BALLOON DID NOT INFLATE. THE SAME INFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER WAS REMOVED EASILY. A SECOND AVIATOR WAS USED AND WHEN ATTEMPTING TO FLUSH IT FROM THE TIP, THE SALINE DID NOT COME OUT OF THE WIRE EXIT PORT. THERE WAS NO REPORTED PATIENT INJURY. A NON STERILE AVIATOR PLUS .014 4.0X20 142CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED. DRY BLOOD RESIDUES WERE OBSERVED IN THE BALLOON. A KINK WAS NOTED IN THE INNER BODY/OUTER MEMBER SUBASSEMBLY AT 19 CM APPROXIMATELY FROM DISTAL TIP END. AN ATTEMPT TO INFLATE THE BALLOON AT 14 ATM WAS MADE, THE BALLOON WAS SUCCESSFULLY INFLATED AND NO LEAKAGE WAS NOTED. 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 HOLE IN THE REPORTED KINK WAS NOT CONFIRMED, HOWEVER THE KINK NEAR TO THE BACK END OF THE SHAFT WAS CONFIRMED, THE EXACT CAUSE OF THE KINK FAILURE COULD NOT BE DETERMINED. THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE BALLOON CATHETER SHAFT SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THERE WERE VESSEL CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9610978-2010-00162 AND 9610978-2010-00167.

    Description of Event or Problem · 1

    AS IT WAS REPORTED BY THE SALES-REP VIA FAX: THE FIRST AVIATOR BALLOON USED BY THE PHYSICIAN (AVIATOR PLUS .014 4.0X20 142CM) HAD A KINK NEAR THE BACK END OF THE SHAFT, IT WAS ALSO NOTED THAT KINK ACTUALLY HAD A HOLE IN IT. THE SECOND AVIATOR BALLOON (AVIATOR PLUS .014 4.0X20 142CM) HAD A KINK IN THE TIP OF THE BALLOON AND THE PHYSICIAN ENCOUNTERED DIFFICULTY TRACKING THE DEVICE TO THE LESION. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD AVIATOR BALLOON. THE KINK WAS NOTICED IT WHEN THE TECH PULLED IT FROM THE BACK TABLE TO HAND TO THE PHYSICIAN. IT WAS ALREADY OUT OF THE COIL TUBING AND PREPPED ON THE TABLE. AS FAR AS THE SALES REP COULD DETERMINE THE DEVICE WAS HANDLED AND PREPPED PER IFU. THERE IS A CHANCE IT COULD HAVE BEEN KINKED BY THE TECH BUT WAS NOT NOTED BY THE SALES REP OR BY THE TECH. THE DEVICE WAS USED IN THE PATIENT TO TREAT A LESION IN THE LEFT INTERNAL CAROTID ARTERY WITH 95% STENOSIS. IT WAS IN PLACE IN THE LEFT INTERNAL CAROTID ARTERY AND WHEN THE TECH WENT TO INFLATE IT USING A BOSTON SCIENTIFIC ENCORE SHE NOTICED THE DYE SHOOTING OUT OF THE HOLE IN THE CATHETER WHERE IT WAS KINKED. THE BALLOON DID NOT INFLATE. THE SAME INFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. IT DID NOT INFLATE NORMALLY AND LEAKAGE WAS NOTED FROM THE KINKED AREA ON THE CATHETER. THE BALLOON CATHETER WAS REMOVED EASILY. A SECOND AVIATOR WAS USED AND WHEN ATTEMPTING TO FLUSH IT FROM THE TIP, THE SALINE DID NOT COME OUT OF THE WIRE EXIT PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15126446

    Patients

    Seq Age Sex Outcome Treatment
    1