BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3772314 · Received April 25, 2014

    Report

    Report Number
    9612164-2014-00445
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED. (NO DEVICE RECEIVED FOR EVALUATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (80% STENOSIS, SEVERE CALCIFICATION AND MODERATE VESSEL TORTUOSITY). CONCLUSION RESULTS: DEVICE FAILURE RELATED TO PATIENT CONDITION (80% STENOSIS, SEVERE CALCIFICATION AND MODERATE VESSEL TORTUOSITY). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION PROBLEM; FAILURE TO FOLLOW INSTRUCTIONS (USED ABOVE THE RATED BURST PRESSURE). CONCLUSION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (USED ABOVE RATED BURST PRESSURE). (B)(4).

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED AND PARTIALLY FLATTENED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. THE BALLOON MATERIAL WAS TORN IN A RADIAL PATTERN AT THE MID-POINT OF THE BALLOON WORKING LENGTH. THE BALLOON MATERIAL WAS JAGGED AND UNEVEN AT THE TEAR SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A LESION IN THE CIRCUMFLEX WITH 80% STENOSIS, SEVERE CALCIFICATION AND MODERATE VESSEL TORTUOSITY, THE PHYSICIAN ATTEMPTED TO USE A 2.50MM DIAMETER X 15MM LENGTH SPRINTER LEGEND BALLOON. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. IT IS REPORTED THAT THE DEVICE BURST DURING 1ST INFLATION, AT 16 ATM. THE PHYSICIAN PROCEEDED TO USE A 3.0MM DIAMETER X 12MM LENGTH NC SPRINTER BALLOON. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT STRETCHING OCCURRED AT THE TIP AND THAT THE BALLOON DETACHED IN THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED MATERIAL BUT WERE UNSUCCESSFUL AND THE PHYSICIAN COMPLETED THE PROCEDURE BY DEPLOYING A STENT THAT TRAPPED THE DETACHED MATERIAL. IT IS REPORTED THAT THE PATIENT IS FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252627 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 207848242

    Patients

    Seq Age Sex Outcome Treatment
    1