BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC SPRINTER RX

    MDR report key: 3112979 · Received May 15, 2013

    Report

    Report Number
    9612164-2013-00533
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (BALLOON INFLATED TO 21ATMS (RBP = 18ATMS). THIS HAS MOST LIKELY CONTRIBUTED TO THE OUTER DISTAL SHAFT BURST) - DEFORMATION PROBLEM. RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF THE ISSUE IS MOST LIKELY PROCEDURAL RELATED). EVALUATION CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT.(ROOT CAUSE OF THE ISSUE IS MOST LIKELY PROCEDURAL RELATED). USER ERROR CONTRIBUTED TO EVENT (BALLOON INFLATED TO 21ATMS (RBP = 18ATMS). THIS HAS MOST LIKELY CONTRIBUTED TO THE OUTER DISTAL SHAFT BURST).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A 3.5X15MM NC SPRINTER RX BALLOON TO POST DILATE A 3.00X18MM INTEGRITY STENT IN THE MID LEFT CIRCUMFLEX ARTERY. THE FIRST INFLATION OF THE NC SPRINTER WAS TO 18 ATM FOR 0:24 SECONDS. THE BALLOON WAS THEN MOVED PROXIMALLY INSIDE THE STENT AND THE SECOND INFLATION WAS TO 21 ATM FOR 0:19 SECONDS. HOWEVER, IT WAS REPORTED THAT, AFTER THE 2ND DEFLATION, THE BALLOON FAILED TO DEFLATE. THE BALLOON APPEARED TO BE RUPTURED IN THE MID PORTION AND REMAINED INFLATED PROXIMAL AND DISTALLY. REPEAT INFLATION AND DEFLATION DEFLATED THE BALLOON FROM THE MID TO THE PROXIMAL PORTION WERE ATTEMPTED BUT THE DISTAL PORTION OF THE BALLOON REMAINED INFLATED. A FIELDER XT WIRE WAS INTRODUCED TO RUPTURE THE DISTAL END OF THE BALLOON. THIS WAS UNSUCCESSFUL. AFTER CONFIRMING THE BALLOON WAS NOT ANCHORED IN THE VESSEL THE BALLOON WAS GENTLY RETRACTED INTO THE GUIDE AND REMOVED WITHOUT ANGIOGRAPHIC VISIBLE DAMAGE TO THE VESSEL OR STENT. WHEN THE BALLOON WAS FINALLY REMOVED AND INSPECTED, THE BALLOON APPEARED TO BE RUPTURED PROXIMALLY AND NECKED IN THE MIDDLE. THE DISTAL END REMAINED INFLATED. THE BALLOON WAS REMOVED ENTIRELY AND NOTHING WAS NOTED TO REMAIN IN THE PATIENT'S ARTERY. THERE WAS NOTHING UNUSUAL NOTED BY THE PHYSICIAN WHILST PREPARING THE BALLOON BEFORE USE. NO CLINICAL SEQUELAE WERE REPORTED. PRODUCT EVALUATION: THE BALLOON HAD BEEN INFLATED. BLOOD WAS PRESENT INSIDE THE BALLOON, DISTAL SHAFT AND LUER. THERE WAS A 1.2CM LONGITUDINAL TEAR ON THE DISTAL SHAFT. THE TEAR WAS LOCATED IMMEDIATELY PROXIMAL TO THE BALLOON BOND. THE TORN PORTION OF DISTAL SHAFT APPEARED TO HAVE BEEN INFLATED. THE HYPOTUBE WAS KINKED IN NUMEROUS PLACES. THE BALLOON BOND WAS NECKED. THE DISTAL BALLOON MATERIAL WAS BUNCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214617 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 206682414

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention