BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRA 2 MONORIAL CUTTING BALLOON

    MDR report key: 840468 · Received April 10, 2007

    Report

    Report Number
    3004878732-2007-00018
    Event Type
    Death
    Date Received
    April 10, 2007
    Date of Event
    February 15, 2007
    Report Date
    March 12, 2007
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS CONFIRMED THAT THIS DEVICE HAS BEEN DISPOSED OF; THEREFORE, NO DIRECT PRODUCT ANALYSIS CAN BE COMPLETED AND NO ROOT CAUSE DETERMINATION CAN BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTION OF THE ULTRA2 CUTTING BALLOON SEPARATED, AND THE PATIENT LATER EXPIRED. PATIENT WAS ADMITTED FOR PERCUTANEOUS AORTIC VALVULOPLASTY, WHICH WAS SUCCESSFULLY COMPLETED WITH IMPROVEMENT IN HER AORTIC VALVE AREA FROM .2 TO .9 CM SQUARED. CORONARY ANGIOGRAPHY SHOWED SEVERE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY DISEASE, AS WELL AS SEVERE DISTAL RIGHT CORONARY ARTERY (RCA) DISEASE. ATTEMPTS WERE MADE TO PREDILATE THE 90% STENOSED LESION IN THE SEVERELY CALCIFIED PROXIMAL LAD WITH A 2.75 X 20MM QUANTUM MAVERICK BALLOON; HOWEVER, TWO INFLATIONS TO 20 ATMS RESULTED IN A "DOG-BONE" EFFECT. THE ULTRA 2 CUTTING BALLOON WAS THEN ADVANCED; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. BLOOD WAS FOUND IN THE ULTRA2 CUTTING BALLOON CATHETER, AND ATTEMPTS WERE MADE TO WITHDRAW IT. A PIECE OF THE BALLOON SEPARATED, AND REMAINED IN THE MID LAD OF THE PT FOLLOWING REMOVAL OF THE REST OF THE BALLOON CATHETER. ATTEMPTS WERE MADE TO RETRIEVE THE PIECE OF THE CUTTING BALLOON, HOWEVER, THESE WERE UNSUCCESSFUL. THE TIP MIGRATED TO "A VERY DISTAL OBTUSE MARGINAL BRANCH", AND REMAINS IN THE PT. PER CINE REVIEW, THE LAD WAS OCCLUDED PROXIMALLY AROUND THE LESION, AND THERE WAS A VERY SEVERE DISSECTION ORIGINATING JUST PROXIMAL TO THE LESION AND GOING DOWN PARALLEL TO THE LESION. THE VESSEL WAS WIRED IN THE FALSE LUMEN. DILATION WAS PERFORMED CAUSING FURTHER DISSECTION OF THE DISTAL LAD. FOUR BARE METAL STENTS WERE THEN IMPLANTED, WITH ONLY ONE BEING IMPLANTED IN THE TRUE LUMEN; THE OTHER THREE WERE LOCATED IN THE FALSE LUMEN. THE PATIENT SUFFERED A CARDIAC ARREST DURING THE PROCEDURE AND WAS STARTED ON PRESSORS, AS WELL AS HAVING AN INTRA-AORTIC BALLOON PUMP PLACED. THE PATIENT REMAINED HOSPITALIZED, INTUBATED AND SEDATED THROUGHOUT HER HOSP STAY. THE PATIENT WAS TAKEN TO THE CCU AND RECEIVED FLUIDS AND BICARBONATE, AND WAS WEANED OFF OF IABP SUPPORT. HER CARDIAC FUNCTION SEEMED TO IMPROVE; HOWEVER, SHE DID EVENTUALLY DEVELOP PROGRESSIVE SEPSIS, WHICH FAILED TO RESPOND TO BROAD-SPECTRUM ANTIBIOTICS. IT WAS REPORTED BY THE FACILITY THAT THE MOST LIKELY SOURCE OF INFECTION WAS PENUMONIA, ALTHOUGH THE PT HAD PLEURAL EFFUSIONS AS WELL. THE PT DEVELOPED PROGRESSIVE RENAL FAILURE, THEN ASYSTOLIC ARREST, AND FURTHER INTERVENTION WAS DECLINED BY THE FAMILY. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA 2 MONORIAL CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BSC LETTERKENNY NA EG0949

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death