BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2820223 · Received November 6, 2012

    Report

    Report Number
    2134265-2012-06666
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMERGE CATHETER WAS RECEIVED FOR ANALYSIS. THE PROXIMAL PORTION OF THE HYPOTUBE WAS COMPLETELY SEPARATED 71.5 CM FROM THE EDGE OF THE STRAIN RELIEF. THE MID-SECTION PORTION (PROXIMAL END OF PROXIMAL HYPOTUBE SEPARATION TO THE PROXIMAL END OF DISTAL HYPOTUBE SEPARATION) MEASURED 32 CM. THE DISTAL PORTION OF THE HYPOTUBE WAS SEPARATED 39.5 CM FROM THE DISTAL TIP. THERE WAS A KINK 6 CM FROM THE FRACTURED END IN THE MID-SECTION PORTION OF THE HYPOTUBE. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE WAS NO EVIDENCE THAT THE SEPARATION AND KINK WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRODUCTION OF A PCI (PERCUTANEOUS CORONARY INTERVENTION) PROCEDURE, A SHAFT BREAK OCCURRED. AFTER POSITIONING TWO BMW WIRES INTO THE NON-BSC GUIDE CATHETER, THE EMERGE BALLOON 20 X 2.50 MM WAS ADVANCED ONTO ONE OF THE WIRES. AFTER PUSHING THE BALLOON APPROXIMATELY 20 CM INTO THE CATHETER, RESISTANCE WAS FELT. THE BALLOON WAS MANIPULATED AND A KINK IN THE PROXIMAL SECTION OF THE BALLOON SHAFT OCCURRED. IN TRYING TO STRAIGHTEN THIS OUT, THE BALLOON CATHETER SHAFT SNAPPED IN TWO. THE BREAK OCCURRED OUTSIDE OF THE PATIENT. THE DISTAL SECTION OF THE BALLOON WAS EASILY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRODUCTION OF A PCI (PERCUTANEOUS CORONARY INTERVENTION) PROCEDURE, A SHAFT BREAK OCCURRED. AFTER POSITIONING TWO BMW WIRES INTO THE NON-BSC GUIDE CATHETER, THE EMERGE BALLOON 20X2.50MM WAS ADVANCED ONTO ONE OF THE WIRES. AFTER PUSHING THE BALLOON APPROXIMATELY 20 CM INTO THE CATHETER, RESISTANCE WAS FELT. THE BALLOON WAS MANIPULATED AND A KINK IN THE PROXIMAL SECTION OF THE BALLOON SHAFT OCCURRED. IN TRYING TO STRAIGHTEN THIS OUT, THE BALLOON CATHETER SHAFT SNAPPED IN TWO. THE BREAK OCCURRED OUTSIDE OF THE PATIENT. THE DISTAL SECTION OF THE BALLOON WAS EASILY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919320250 15408909

    Patients

    Seq Age Sex Outcome Treatment
    1