BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2170680 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05061
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ASAHI GUIDE WIRE IS BEING FILED UNDER A SEPARATE MFR NUMBER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED ARMADA DILATATION CATHETER NOTED BLOOD IN THE GUIDE WIRE LUMEN AND ON THE BALLOON AND CONTRAST IN THE BALLOON AND INFLATION LUMEN, THIS IS CONSISTENT WITH THE CATHETER BEING ADVANCED OVER A GUIDE WIRE AND INTO THE ANATOMY. THE BALLOON WAS LOOSELY FOLDED. THE TIP WAS FOLDED IN ON ITSELF, FOR A LENGTH OF 3 MM. THE DISTAL END OF THE BALLOON WAS ALSO FOLDED IN ON ITSELF. THERE WERE MULTIPLE KINKS THROUGH OUT THE ENTIRE LENGTH OF THE SHAFT. THE INNER MEMBER WAS KINKED AND BUNCHED INSIDE THE HUB. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE GUIDE WIRE USED DURING THE PROCEDURE WAS NOT RETURNED. A FULL LENGTH MANDREL WAS USED IN ATTEMPT TO MEASURE THE INNER DIAMETER OF THE GUIDE WIRE LUMEN. BUT THE FULL LENGTH MANDREL WOULD NOT ADVANCE PAST THE DAMAGED TIP NOTED. A NEW .014 INCH GUIDE WIRE WAS USED IN AN ATTEMPT TO PERFORM THE GUIDE WIRE MOVEMENT TEST FIRST WITH THE RETURNED BALLOON CATHETER STRAIGHT THEN LOOPED. BUT THE GUIDE WIRE WOULD NOT ADVANCE PAST THE DAMAGE TIP NOTED. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO RATED BURST PRESSURE, WHEN IT WAS OBSERVED THAT FLUID WAS COMING OUT OF THE GUIDE WIRE LUMEN PORT OF THE HUB. FACTORS THAT MAY CONTRIBUTE TO THE RESISTANCE BETWEEN BALLOON CATHETER AND GUIDE WIRE MAY INCLUDE, BUT ARE NOT LIMITED TO, PRODUCT PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, OR DAMAGE TO THE DISTAL SHAFT OF THE BALLOON CATHETER. OTHER FACTORS MAY ALSO CONSIST OF ANATOMICAL CONDITIONS, SUCH AS TORTUOUS VESSELS, AS THEY COULD CAUSE THE SHAPE OF THE GUIDE WIRE OR CATHETER TO BECOME ANGLED AND MAKE IT MORE DIFFICULT TO ADVANCE THE CATHETER OVER THE GUIDE WIRE. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. IN CERTAIN CIRCUMSTANCES, SUCH AS MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND COULD LEAD TO RESISTANCE. IT APPEARS THAT RESISTANCE LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY, AS A RESULT, CONTINUED ATTEMPTS TO ADVANCE AGAINST RESISTANCE LIKELY CAUSED THE PROLAPSE OF THE BALLOON AND TIP. FURTHERMORE, THE CONTINUED ATTEMPTS TO ADVANCE AGAINST RESISTANCE LIKELY CAUSED THE KINKS NOTED ON THE SHAFT AND IN THE SIDEARM OF THE DEVICE. AS A RESULT OF THE BUNCHING/KINK TO THE INNER LUMEN IN THE SIDEARM, THIS LIKELY CAUSED THE LEAKING OBSERVED AT THIS AREA. BECAUSE IT WAS NOTED THAT THE ARMADA WAS ADVANCED AGAINST RESISTANCE, IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTION FOR USE (IFU) STATES: DO NOT ADVANCE THE ARMADA 14 PTA CATHETER AGAINST SIGNIFICANT RESISTANCE. THE CAUSE OF RESISTANCE SHOULD BE DETERMINED VIA FLUOROSCOPY AND REMEDIAL ACTION TAKEN. IN THIS CASE, IT COULD NOT BE DETERMINED IF FAILING TO FOLLOW THE IFU INSTRUCTIONS CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, THE REPORTED DIFFICULTIES AND SUBSEQUENT DAMAGE NOTED TO THE ARMADA APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL BALLOON CATHETERS ARE SUBJECT TO A VISUAL INSPECTION. ADDITIONALLY, THE PROFILE DIMENSIONS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 99% DIFFUSED RIGHT ANTERIOR TIBIAL ARTERY. AFTER PLACING A PROWATER GUIDE WIRE, THE ARMADA BALLOON CATHETER WAS ADVANCED, BUT RESISTANCE WAS MET AND AS IT WAS PUSHED FORWARD TO GET TO THE LESION, THE END OF THE CATHETER PROLAPSED INTO THE PERINEAL ARTERY. THE BALLOON WAS INFLATED TWICE TO 12 ATMOSPHERES IN THE PROLAPSED STATE. THE DECISION WAS MADE TO EXCHANGE THE PROWATER GUIDE WIRE FOR A MORE SUPPORTIVE GUIDE WIRE, BUT AS THE PROWATER WAS REMOVED, RESISTANCE WAS MET (WITH THE CATHETER) AND ONCE IT WAS REMOVED, IT WAS OBSERVED TO BE KINKED AT THE AREA WHERE THE BALLOON HAD PROLAPSED. AN ATTEMPT WAS MADE TO ADVANCE A GRANDSLAM GUIDE WIRE, BUT RESISTANCE WAS AGAIN MET WITH THE ARMADA, SO IT WAS REMOVED. THE ARMADA WAS THEN REMOVED FROM THE PATIENT TO BE FLUSHED. WHILE FLUSHING THE LUMEN, FLUID WAS NOTED COMING OUT OF THE BALLOON PORT. A NEW ARMADA BALLOON CATHETER WAS USED SUCCESSFULLY WITH THE GRANDSLAM GUIDE WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 698092

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GUIDE WIRE: GRANDSLAM, ASAHI PROWATER