BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 19849380 · Received July 29, 2024

    Report

    Report Number
    9612164-2024-03451
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 14, 2024
    Report Date
    September 9, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    K103095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE LESION BEING TREATED WAS A NON-CALCIFIED LESION WITH 95% STENOSIS AT THE NARROWEST POINT IN THE MIDDLE PART OF THE CIRCUMFLEX ARTERY. THE PATIENT HAD MULTIPLE LESION AND THE SURGERY PRIORITIZED RESOLVING THE NARROWEST PART. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. NEGATIVE PREP/PURGING WAS NOT PERFORMED ON THE DEVICE PRIOR TO USE. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE BALLOON RUPTURE OCCURRED ON THE FIRST INFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE REPLACEMENT DEVICE WAS A MEDTRONIC BALLOON CATHETER OF THE SAME SPECIFICATION WITH NO ISSUES NOTED. PATIENT GENDER PROVIDED. IMAGE ANALYSIS: A STILL IMAGE WAS RECEIVED FOR ANALYSIS. THE STILL IMAGE SHOWED CONTRAST INJECTION INTO THE RIGHT CORONARY ARTERY (RCA). THE NARROWEST PART OF THE RCA IS CIRCLED. NO EVIDENCE OF THE PRESENCE OF A BALLOON CATHETER OR BALLOON BURST OF A BALLOON CATHETER. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX D CODE ADDED. 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 SPRINTER LEGEND CORONARY BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT DURING THE PROCEDURE THE DEVICE RUPTURED WHEN THE PRESSURE REACHED 10 KILOPASCALS (KPH). THE DEVICE WAS DEACTIVATED AND REPLACED IMMEDIATELY WITH A NEW BALLOON DILATATION CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951958 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, LOX MEDTRONIC MEXICO SPL12515X 225213614

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male