BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO2

    MDR report key: 1001918 · Received February 21, 2008

    Report

    Report Number
    2939204-2008-00051
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAVASCULAR ULTRASOUND CATHETER (IVUS) DISTAL TIP DETACHED IN THE PT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY MID, 90% STENOSED, MODERATE TORTUOUS WITH NO CALCIFICATION. THE IVUS WAS USED TO EVAL THE LESION AT PRE-BALLOONING. GOOD IMAGE WAS OBTAINED, DEVICE WAS REMOVED WITHOUT ISSUE. THE PHYSICIAN DID NOT OBSERVE ANY ABNORMALITIES WITH THE IVUS CATHETER AND NO RESISTANCE WAS ENCOUNTERED DURING USE. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE A BALLOON CATHETER, HE NOTICED AN ADD'L RADIOPAQUE MARKER UNDER FLUOROSCOPY. HE DETERMINED THE DISTAL TIP OF THE CATHETER HAD DETACHED AND REMAINED INSIDE THE PT'S BODY. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO RETRIEVE THE DISTAL SECTION OF THE DEVICE FROM THE VASCULATURE, BUT WAS NOT SUCCESSFUL. A GUIDEWIRE WAS INSERTED AND A BALLOON CATHETER WAS INSERTED AND ADVANCED DISTAL TO THE LOCATION OF THE DETACHED TIP. THE BALLOON CATHETER WAS INFLATED AND WITHDRAWN PROXIMALLY, ALLOWING THE DETACHED TIP TO MOVE PROXIMAL. THE PHYSICIAN CONTINUED THIS TECHNIQUE WITH SEVERAL SIZES OF BALLOON CATHETERS UNTIL HE SUCCESSFULLY MOVED THE DETACHED TIP TO THE LAD PROXIMAL, WHERE A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE TIP FROM THE PT'S BODY. THE PT SUSTAINED NO INJURY AND IS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO2 CORONARY IMAGING CATHETERS DQO BOSTON SCIENTIFIC CORP. 39014 9631950

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention TERUMO RUNTHROUGH NS GUIDEWIRE| GUIDE CATHETER MACH 1| INTRODUCER SHEATH MEDIKIT