BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 4210268 · Received October 29, 2014

    Report

    Report Number
    2134265-2014-06860
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE HYPOTUBE SHAFT WAS COMPLETELY SEPARATED 92.5CM FROM THE HUB. THE FRACTURE FACES WERE OVAL. THERE WERE NUMEROUS HYPOTUBE KINKS. THERE WAS NO DAMAGE OR IRREGULARITIES TO THE SHAFT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE MANUFACTURING BATCH 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). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO LOAD A 2.50MM X 12MM EMERGE¿ BALLOON CATHETER OVER AN UNSPECIFIED GUIDE WIRE HOWEVER IT WAS NOTED THAT THE HYPOTUBE SEPARATED WHERE IT IS CONNECTED TO THE BALLOON AT THE WELL POINT. THERE WAS NO KINK NOTED ON THE DEVICE. THE PROCEDURE WAS COMPLETED ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO LOAD A 2.50MM X 12MM EMERGE¿ BALLOON CATHETER OVER AN UNSPECIFIED GUIDE WIRE HOWEVER IT WAS NOTED THAT THE HYPOTUBE SEPARATED WHERE IT IS CONNECTED TO THE BALLOON AT THE WELL POINT. THERE WAS NO KINK NOTED ON THE DEVICE. THE PROCEDURE WAS COMPLETED ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693286 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918912250 17143476

    Patients

    Seq Age Sex Outcome Treatment
    1