BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET SPIROFLEX RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 1828336 · Received September 1, 2010

    Report

    Report Number
    2183460-2010-00007
    Event Type
    Other
    Date Received
    September 1, 2010
    Date of Event
    July 15, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDRAD INTERVENTIONAL / POSSIS
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SITE STATED THAT THE TIP OF ANGIOJET CATHETER SHEARED OFF IN PERIPHERAL BLOOD VESSEL. INSPECTED THE RETURNED ULTRA SPIROFLEX RX THROMBECTOMY SET AND NOTICED THAT THE SUPPLY LINE HAD BEEN CUT OFF NEAR THE CATHETER MANIFOLD AND THE PUMP END WAS NOT RETURNED. ALSO NOTICED THAT THE TIP, TUBING, AND HYPO TUBE HAD BEEN BROKE OFF APPROX THREE INCHES DISTAL OF THE MID-JOINT. NOT ABLE TO PERFORM A FUNCTIONAL TEST DUE TO ONLY A PORTION OF THE THROMBECTOMY SET BEING RETURNED. CLINICAL SUMMARY: THIS EVENT CONSISTS OF A BROKEN DEVICE DURING AN ANGIOJET THERAPY PROCEDURE. THE PT IS AN (B)(6) FEMALE WITH A HISTORY OF PERIPHERAL VASCULAR DISEASE (PVD), CHRONIC LIMB ISCHEMIA, CELLULITIS, BILATERAL NON HEALING ULCERS (LEFT WORSE THAN RIGHT), AND SEVERE BILATERAL CLAUDICATION. THE PT WAS PRESENTED TO THE CATH LAB AND UNDERWENT AN ANGIOGRAM VIA RIGHT FEMORAL ACCESS TO VISUALIZE THE BILATERAL EXTREMITIES. ON THE RIGHT SIDE - THE SUPERIOR SUPERFICIAL FEMORAL ARTERY (SFA) WAS VISUALIZED UNTIL IT TAPERED OFF. IN ADDITION, THE RIGHT POPLITEAL ARTERY WAS ALSO VISUALIZED AND THE LARGE SEGMENT OF LOWER SFA COULD NOT BE SEEN WITH CONTRAST SHOTS. ON THE LEFT SIDE - THE COMMON ILIAC, INTERNAL AND EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES VISUALIZED. THERE WAS A FLUSH LESION OF THE COMMON FEMORAL ARTERY, SO THAT THE TAKE OFF OF THE SFA WAS UNK BUT THE DEEP FEMORAL ARTERY (PROFUNDA) COULD BE SEEN. DECISION WAS MADE TO PLACE PT IN A PRONE POSITION SO THAT POPLITEAL ARTERY COULD BE ACCESSED. A WIRE SENT THROUGH THE POPLITEAL ARTERY ALL THE WAY OUT THROUGH RIGHT FEMORAL ACCESS. THE WIRE SHOWED THE OPENING OF THE LEFT SFA AND THERE WAS NO FLOW THROUGH THE SFA. A STENT WAS PLACED IN THE LEFT SFA JUST DISTAL TO THE OSTIUM OF THE PROFUNDA. THE SFA COULD BE VISUALIZED DOWN TO ANTERIOR TIBIAL ARTERY BUT WITH POOR FLOW AND OPACITIES THOUGHT TO BE THROMBUS. DUE TO LENGTH OF THE CASE IT WAS DECIDED TO DRIP TPA AND THE PROCEDURE WAS CONCLUDED. THE PT WAS BROUGHT BACK TO THE CATH LAB IN THE AFTERNOON. THE LEFT SFA WAS NOW IMPROVED BUT FLOW WAS STILL UNSATISFACTORY. IT WAS DECIDED TO RUN AN ANGIOJET DEVICE (ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET) DOWN TO THE SFA LESION. THE PHYSICIAN THREADED THE ANGIOJET DEVICE OVER THE BEGINNING OF THE 0.014 WIRE (PORTION OF WIRE THAT IS STILL OUTSIDE PT) AND FELT RESISTANCE. THE PHYSICIAN ASKED THE HOSPITAL TECH IF THIS WAS NORMAL AND THE TECH SAID YES. THE PHYSICIAN MOVED THE ANGIOJET DEVICE WITH RESISTANCE CENTIMETER BY CENTIMETER DOWN THE WIRE WITH LITTLE ANGIOGRAPHIC EXPOSURE BECAUSE HE HAD SO MUCH RADIATION EXPOSURE ALREADY. THE END OF THE WIRE WAS DEEP IN THE TIB-PERONEAL TRUNK. THE PHYSICIAN COULD THEN NOT MOVE THE ANGIOJET DEVICE AT ALL. UPON VISUALIZATION, THE ANGIOJET DEVICE WAS STUCK ON THE OPENING OF THE PREVIOUSLY PLACED STENT. ATTEMPTS WERE MADE TO FREE THE ANGIOJET DEVICE W/O SUCCESS UNTIL THE STENT STRETCHED OUT AND THE ANGIOJET DEVICE TIP SHEARED OFF. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE TIP WITH A SNARE DEVICE W/O SUCCESS. THE FLOW IN THE PT'S LEFT LEG GREATLY IMPROVED SINCE THE MORNING'S PROCEDURE. THE CASE WAS CONCLUDED WITH THE ANGIOJET DEVICE TIP STILL IN THE PT. EIGHT DAYS POST ANGIOJET PROCEDURE THE PT WAS BROUGHT BACK TO CATHLAB WITH RIGHT LOWER EXTREMITY PAIN. BY THIS TIME THE LEFT LEG ULCER HAD ALREADY IMPROVED. UPON VISUALIZATION OF LEFT LEG, THE CATHETER TIP REMAINED IN THE OPENING OF THE LEFT SFA AND THE SHEARED END WAS IN THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN DETERMINED THAT THE CATHETER TIP WOULD ENDOTHELIALIZE IN ITS CURRENT PLACE. THE PHYSICIAN FELT THAT THERE WAS LITTLE RISK OF THE DEVICE TIP EMBOLIZING DUE TO THE TIPS LOCATION. IT IS THE PHYSICIAN'S ASSUMPTION THAT THERE WAS A PROBLEM WITH THE MONORAIL CANAL THAT THE WIRE GOES THROUGH IN THE ANGIOJET DEVICE. THE PHYSICIAN ALSO FELT THAT HE SHOULD HAVE KNOWN TO CHANGE ONE ANGIOJET DEVICE FOR ANOTHER WHEN THE ANGIOJET WOULDN'T EASILY PASS OVER THE WIRE FROM THE START OF THE CASE. THIS RESISTANCE WAS FELT EVEN OVER THE SECTION OF WIRE OUTSIDE THE PT'S BODY. THE PHYSICIAN EXPLAINED THAT IT WOULD NOT BE UNUSUAL TO FEEL RESISTANCE WHEN A CATHETER GOES OVER THE WIRE WITHIN THE PT'S BODY BECAUSE WITH TIME DEBRIS MAY BECOME ATTACHED TO THE WIRE ESPECIALLY IN LONG CASES. A PORTION OF THE ANGIOJET DEVICE WAS RETURNED TO MEDRAD AND WAS EXAMINED. HOWEVER, THE DISTAL PORTION OF THE DEVICE WHICH CONTAINS THE RAPID EXCHANGE LUMEN (MONORAIL CANAL AS DESCRIBED BY THE PHYSICIAN) WAS NOT PRESENT SO NO DETERMINATION COULD BE MADE TO WHAT CAUSED THE DEVICE RESISTANCE AS IT PASSED OVER THE WIRE. THIS EVENT IS CONSIDERED REPORTABLE SINCE INTERVENTION WAS ATTEMPTED TO RETRIEVE THE BROKEN DEVICE.

    Description of Event or Problem · 1

    (B)(6), CURRENT DATE (B)(6) 2010, EVENT DATE (B)(6) 2010. PT. IS AN (B)(6) FEMALE, WITH PAST MEDICAL HISTORY OF PVD, CHRONIC LIMB ISCHEMIA, CELLULITIS, B/I NON HEALING ULCERS (LEFT WORSE THAN RIGHT) AND SEVERE B/I CLAUDICATION. BILATERAL LOWER EXTREMITIES WERE VISUALIZED ON ANGIOGRAM VIA RIGHT FEMORAL ACCESS. ON RIGHT SIDE SUPERIOR SUPERFICIAL FEMORAL ARTERY WAS VISUALIZED UNTIL IT TAPERED OFF. RIGHT SIDES POPLITEAL ARTERY ALSO VISUALIZED, LARGE SEGMENT OF LOWER SFA COULD NOT BE SEEN WITH CONTRAST SHOTS. LEFT COMMON ILIAC, INTERNAL AND EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES VISUALIZED. THERE WAS A FLUSH LESION OF THE COMMON FEMORAL ARTERY-SO THAT THE TAKE OFF OF SFA WAS UNK BUT THE DEEP FEMORAL ARTERY (PROFUNDA) COULD BE SEEN. DECISION WAS MADE TO PLACE PT. PRONE SO THAT POPLITEAL ARTERY COULD BE ACCESSED. WIRE STENT THROUGH POPLITEAL ARTERY ALL THE WAY OUT THROUGH RIGHT FEMORAL ACCESS. WIRE NOW SHOWED THE OPENING OF THE LEFT SFA. THERE WAS NO FLOW THROUGH LEFT SFA. STENT WAS PLACED IN LEFT SFA JUST DISTAL TO THE OSTEOM OF THE PROFUNDA. SFA COULD BE VISUALIZED DOWN TO ANTERIOR TIBIAL ARTERY BUT WITH POOR FLOW AND OPACITIES THOUGHT TO BE THROMBUS. DUE TO CASE LENGTH IT WAS DECIDED DRIP TPA. CASE OVER. PT BROUGHT BACK TO THE LAB IN THE AFTERNOON. LEFT SFA NOW IMPROVED BUT FLOW STILL UNSATISFACTORY. IT WAS DECIDED TO RUN ANGIOJET 4F SPIROFLEX CATHETER DOWN SFA LESION. AS DR. (B)(6) THREAD THE AJ CATHETER OVER THE BEGINNING OF THE WIRE (PORTION OF WIRE STILL OUTSIDE THE PT) HE FELT RESISTANCE. HE ASKED THE TECH IF THIS WAS NORMAL AND THE TECH SAID YES. HE MOVED THE AJ CATHETER WITH RESISTANCE CENTIMETER BY CENTIMETER DOWN THE WIRE WITH LITTLE ANGIOGRAPHIC EXPOSURE BECAUSE HE HAD SO MUCH RADIATION EXPOSURE ALREADY. THE END OF THE WIRE WAS DEEP IN THE TIB-PERONEAL TRUNK. FINALLY HE COULD NOT MOVE THE AJ CATHETER AT ALL. UPON VISUALIZATION, THE AJ CATHETER WAS STUCK ON THE OPENING OF THE STENT. ATTEMPTS WERE MADE TO FREE THE AJ CATHETER W/O SUCCESS-UNTIL THE STENT STRETCHED OUT AND THE AJ SPIROFLEX TIP SHEARED OFF. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE TIP WITH A SNARE W/O SUCCESS. FLOW IN LEFT LEG GREATLY IMPROVED SINCE MORNING. CASE ENDED. PT. WAS BROUGHT BACK TO LAB ON (B)(6) 2010, WITH RIGHT LOWER EXTREMITY PAIN. BY THEN LEFT LEG ULCER HAD ALREADY IMPROVED. UPON VISUALIZATION OF LEFT LEG, THE CATHETER TIP REMAINED IN THE OPENING OF THE LEFT SFA AND SHEARED END WAS IN THE LEFT COMMON ILIAC ARTERY. DR. (B)(6) FEELS THAT THE CATHETER WILL ENDOTHELIALIZE IN ITS CURRENT PLACE. HE FEELS THERE IS LITTLE RISK OF THE CATHETER EMBOLIZING. IT IS HIS BEST GUESS THAT THERE WAS A PROBLEM WITH THE MONORAIL CANAL THAT THE WIRE GOES THROUGH IN THE SPIROFLEX. DR. ALSO FEELS THAT HE SHOULD HAVE KNOWN TO CHANGE ONE SPIROFLEX FOR ANOTHER WHEN THE AJ WOULD EASILY PASS OVER THE WIRE FROM THE START OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET SPIROFLEX RHEOLYTIC THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE MEDRAD INTERVENTIONAL / POSSIS 106553-001 97179

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention