BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC SPRINTER RX

    MDR report key: 3221036 · Received July 11, 2013

    Report

    Report Number
    9612164-2013-00706
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    July 11, 2013
    Manufacturer
    MEDTRONIC TIJUANA
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (PROCEDURAL); NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (NO DEVICE OR PROCEDURAL IMAGES PROVIDED). INHERENT RISK OF PROCEDURE- (MI <(>&<)> FAILURE TO DELIVER DEVICE). CONCLUSIONS: INHERENT RISK OF PROCEDURE (MI <(>&<)> FAILURE TO DELIVER DEVICE); NO DEVICE RETURN. UNABLE TO CONFIRM COMPLAINT (NO DEVICE OR IMAGES RETURNED). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO INFLATE A NC SPRINTER RX BALLOON IN THE LAD ARTERY. IT IS REPORTED THAT THE DEVICE WAS INFLATED TO APPROXIMATELY 12 ATMS FOR POST DILATION, DURING THE PROCEDURE, THE BALLOON BURST. IT IS REPORTED THAT THE WIRE MAY HAVE CONTRIBUTED TO THE EVENT. ANOTHER NC SPRINTER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. DURING DELIVERY OF THE NEW NC SPRINTER THE PATIENT STARTED CODING. IT IS REPORTED THAT THE PATIENT WAS REVIVED AFTER A COUPLE OF MINUTES AND BECAME STABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS SUFFERING FROM RESTENOSIS IN TWO PREVIOUS UNKNOWN BRAND STENTS THAT HAD BEEN IMPLANTED IN THE LAD VESSEL. THE PHYSICIAN IMPLANTED A 2.50 X 30 MM RESOLUTE INTEGRITY STENT IN THE LAD TO TREAT THE STENOSIS WITHIN THE STENTS AND BETWEEN THE STENTS. PHYSICIAN THEN USED AN NC SPRINTER 2.5 X 21 MM TO POST DILATE THE STENT. THIS WAS REMOVED WITHOUT DIFFICULTY. THEN THE PREVIOUSLY REPORTED NC SPRINTER 3.00X15 MM RX BALLOON WAS USED TO POST-DILATE A DIFFERENT PART OF THE RESOLUTE INTEGRITY STENT THAT WAS LOCATED IN THE PROXIMAL LAD ARTERY. THIS BALLOON WAS PREVIOUSLY REPORTED TO HAVE RUPTURED AND BURST. THE TECHNICIAN AND PHYSICIAN INDICATED THAT DURING THE NC SPRINTER BALLOON RUPTURE THAT AIR MAY HAVE GOTTEN IN AND THIS MAY HAVE CONTRIBUTED TO THE MI EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320747 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC TIJUANA 206318171

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization