BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC SPRINTER RX

    MDR report key: 20005232 · Received August 20, 2024

    Report

    Report Number
    9612164-2024-03767
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT INSPECTED BEFORE USE. NEGATIVE PREP/PURGING WAS NOT PERFORMED ON THE DEVICE PRIOR TO USE. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. THE BURST OCCURRED AT 6 ATM. NO INFLATIONS WERE PERFORMED PRIOR TO THE ISSUE OCCURRING. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. INTERVENTION WAS NOT REQUIRED DUE TO THE BALLOON BURST. THE PATIENT STATUS IS GOOD, AND THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE BALLOON BURST. PATIENT'S GENDER PROVIDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    AN ATTEMPT WAS MADE TO USE ONE NC SPRINTER BALLOON CATHETER TO POST-DILATE AND RESHAPE AN IMPLANTED STENT. IT WAS REPORTED AFTER PLACING A 3.0 X 14MM HEART STENT IT WAS PLANNED TO USE A 3.0 X 12MM POST-DILATION BALLOON FOR STENT RESHAPING. WHEN THE BALLOON REACHED THE STENT, THE BALLOON WAS INFLATED TO 6KP AND THE BALLOON RUPTURED. IT IS BELIEVED THAT IT WAS CAUSED BY THE SPECIAL LESION SITE O F THE PATIENT. THE BALLOON WAS REPLACED WITH THE SAME BRAND AND MODEL, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE OPERATION TIME WAS PROLONGED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342785 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, LOX MEDTRONIC MEXICO NCSP3012X 228016569

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male