BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER OTW

    MDR report key: 4924737 · Received July 20, 2015

    Report

    Report Number
    9612164-2015-01286
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 31, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS BEING USED TO PRE-DILATE A LESION IN THE DISTAL RCA WITH 75% STENOSIS. NO RESISTANCE WAS ENCOUTERED WHEN ADVANCING THE DEVICE. EVALUATION SUMMARY: THE BALLOON WAS STILL PARTIALLY INFLATED WHICH WAS PREVENTING REMOVAL OF THE DEVICE FROM THE GUIDE CATHETER. THE BALLOON BOND WAS STRETCHED AND MEASURED 2.0MM IN LENGTH. IT WAS NOT POSSIBLE TO DEFLATE OR INFLATE THE BALLOON.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A SPRINTER OTW BALLOON TO TREAT A LESION IN THE RCA. THE PRODUCT INSPECTED WAS AND NEGATIVE PREP WAS PERFORMED PRIOR TO USE WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON WAS INFLATED IN THE RCA LESION BUT WOULD NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE TO DEFLATE USING THE INFLATION DEVICE INITIALLY AND THEN MANUALLY WITH A SYRINGE. THE BALLOON STILL WOULD NOT DEFLATE. THE BALLOON, WIRE AND THE GUIDE HAD TO BE PULLED BACK WITH THE BALLOON INFLATED TO REMOVE IT FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470356 SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC IRELAND 0007237330

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR