BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA 2 MONORAIL CUTTING BALLOON OUS

    MDR report key: 1063808 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01713
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    March 11, 2008
    Report Date
    June 16, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS VERIFIED THE DIFFICULTY STATED IN THE COMPLAINT. UPON VISUAL INSPECTION, A HOLE WAS NOTED FROM THE MID SECTION TO THE DISTAL END OF THE BALLOON; THEREFORE, NO INFLATION WAS POSSIBLE. A 0.014" GUIDE WIRE WAS UNABLE TO BE COMPLETELY INSERTED INTO THE CATHETER, DUE TO CONGEALED BLOOD IN THE INNER LUMEN. ONE BLADE PAD WAS TORN FROM THE PROXIMAL END TO THE DISTAL END OF THE BALLOON. IT WAS CONFIRMED THAT NO PART OF THE BLADE WAS MISSING. THE OTHER THREE BLADES WERE ADHERED TO THE BALLOON SURFACE. THE MARKER BANDS WERE INTACT AND THE DISTANCE BETWEEN THE MARKER BANDS WAS WITHIN SPECIFICATION. NO ELONGATION WAS PRESENT ON THE DISTAL SHAFT AND NO DAMAGE WAS NOTED ON THE DISTAL TIP OR THE REMAINDER OF THE CATHETER. THE SHOP FLOOR PAPERWORK HAS BEEN REVIEWED, AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SHOP FLOOR PAPERWORK REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    EVENT BECAME REPORTABLE BASED UPON ANALYSIS COMPLETED ON 06/16/2008. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, INSERTION DIFFICULTIES WERE ENCOUNTERED. THE 85% STENOTIC DE NOVO LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE 3.5X10MM ULTRA2 MONORAIL CUTTING BALLOON. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "GOOD". ANALYSIS REVEALED A BLADE/PAD PARTIAL DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA 2 MONORAIL CUTTING BALLOON OUS LOX, CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BSC LETTERKENNY NA EH0818

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR