BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1559481 · Received December 10, 2009

    Report

    Report Number
    2939204-2009-00906
    Event Type
    Injury
    Date Received
    December 10, 2009
    Date of Event
    November 16, 2009
    Report Date
    November 16, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND FOUND NOTHING RELEVANT TO THE REPORTED EVENT. NO SIMILAR COMPLAINTS WERE FOUND IN THIS LOT. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR DFU CONTAINS THESE WARNINGS:DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS.IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. A CATHETER THAT IS FORCIBLY REMOVED MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS.THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE.A ROOT CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THIS COMPLAINT AS THE PRODUCT WAS DISPOSED OF BY THE FACILITY AND NO ANALYSIS COULD BE PERFORMED. HOWEVER, IT APPEARS THAT PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A LESION IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED INTO THE PATIENT, THE CATHETER¿S TRANSDUCER STOPPED ROTATING AND THE CATHETER WAS REMOVED FROM THE PATIENT WITH DIFFICULTY. THE IVUS WAS AGAIN ADVANCED INTO THE PATIENT; WHEN THE CATHETER BROKE INTO TWO PIECES. THE BREAK WAS ON THE PROXIMAL PORTION OF THE CLEAR TUBE (THE PORTION OUTSIDE OF THE PATIENT). THE PHYSICIAN REPORTED THE CATHETER WAS EITHER STUCK IN THE VESSEL OR ON THE GUIDEWIRE AS HE WAS UNABLE TO REMOVE THE IVUS OR THE GUIDEWIRE. IN AN ATTEMPT TO FREE THE DEVICE THE PHYSICIAN ADVANCED A GUIDEWIRE INTO THE GUIDE CATHETER NEXT TO THE IVUS AND RELEASED THE IVUS. THE IVUS AND THE GUIDEWIRE WERE REMOVED TOGETHER. THE PATIENT IS REPORTED TO BE IN ¿FINE¿ CONDITION.

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A LESION IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED INTO THE PT, THE CATHETER'S TRANSDUCER STOPPED ROTATING AND THE CATHETER WAS REMOVED FROM THE PT WITH DIFFICULTY. THE IVUS WAS AGAIN ADVANCED INTO THE PT; WHEN THE CATHETER BROKE INTO TWO PIECES. THE BREAK WAS ON THE PROXIMAL PORTION OF THE CLEAR TUBE (THE PORTION OUTSIDE OF THE PT). THE PHYSICIAN REPORTED THE CATHETER WAS EITHER STUCK IN THE VESSEL OR ON THE GUIDEWIRE AS HE WAS UNABLE TO REMOVE THE IVUS OR THE GUIDEWIRE. IN AN ATTEMPT TO FREE THE DEVICE, THE PHYSICIAN ADVANCED A GUIDEWIRE INTO THE GUIDE CATHETER NEXT TO THE IVUS AND RELEASED THE IVUS. THE IVUS AND THE GUIDEWIRE WERE REMOVED TOGETHER. THE PT IS REPORTED TO BE IN "FINE" CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICROSS 40 MHZ CORONARY IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC CORP. H749518050 12909004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE: BMW 180CM MONORAIL, ABBOTT| GUIDE CATHETER: MEDTRONIC 7F, MEDTRONIC