BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOREFLEX NC SCORING PTCA CATHETER

    MDR report key: 19318156 · Received May 15, 2024

    Report

    Report Number
    3003775186-2024-00156
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    March 26, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD
    Product Code
    NWX
    UDI-DI
    06934955936258
    PMA / PMN Number
    P200041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE GOT AWARE OF THIS CASE (OUR INTERNAL REFERENCE NO. IS (B)(4)) ON 2024/3/30 AND MADE A NOT REPORTABLE DECISION AFTER OUR ANALYSIS OF THE COMPLAINT DESCRIPTION. THEN WE RECEIVED TWO MEDICAL DEVICE USER REPORTS MW5153514 & MW5153515 CONCERNING THIS CASE FROM FDA ON 2024/4/11. AFTER SEVERAL COMMUNICATIONS WITH OUR CUSTOMER ABBOTT TO CHECK AND TO TRY TO GET ADDITIONAL INFORMATION LATER, WE STILL DID NOT GET THE OTHER MORE INFORMATION THAN WE RECEIVED AT FIRST. SINCE THERE IS NO SIGN OF REPORTING AND THERE IS NO PATIENT COMPLICATION FROM OUR RE-ANALYSIS OF THE CASE, WE THEN MADE THE SECOND NOT REPORTABLE DECISION AFTER. AFTER THAT, WE RECEIVED THE RETURNED PRODUCT OF THIS CASE ON 2024/5/2 AND FOUND THAT THE TIP OF THE RETURNED PRODUCT WAS FRACTURED AND MISSING, WE CANNOT MAKE SURE WHERE THE MISSING TIP IS, ON THE PRINCIPLE OF REPORTING WHEN SUSPICIOUS, WE REPORT THIS CASE OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    MULTIPLE NON-CSI/NON-ABBOTT BALLOONS WERE ATTEMPTED TO BE USED IN A SUPER TIGHT PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION, HOWEVER, THE BALLOONS RUPTURED. A SCOREFLEX BALLOON WAS ATTEMPTED TO BE USED IN THE LAD WHEN IT BACKED THE GUIDE UP AND THE WIRE LOOP WAS BEHIND THE SHORT RAPID EXCHANGE CATHETER. THE PHYSICIAN PROCEEDED TO PULL THE BALLOON WITH THE LOOP AND THE BALLOON CAME OFF OF THE WIRE. THE ENTIRE WIRE AND TELEFLEX GUIDELINER WERE PULLED OUT OF THE PATIENT. IT APPEARED THAT THE RAPID EXCHANGE CATHETER MAY HAVE SPLIT, BUT THIS WAS UNABLE TO BE CONFIRMED. THE GUIDELINER WAS FLUSHED AND THE PHYSICIAN RE-WIRED WITH A NEW WIRE TO COMPLETE THE PROCEDURE. BACKGROUND: A SUPER TIGHT PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. IT WAS REPORTED AS NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383278 SCOREFLEX NC SCORING PTCA CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD 3624952208 06934955936258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other