BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ PROXI

    MDR report key: 6176790 · Received December 15, 2016

    Report

    Report Number
    2134265-2016-11695
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    KRA
    PMA / PMN Number
    K101406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ERROR CODE OCCURRED DURING ASPIRATION. THE TARGET TREATMENT LOCATION WAS IN THE LEFT ILIAC VEIN. AN ANGIOJET® SOLENT¿ PROXI CATHETER WAS PRIMED AND ADVANCED TO THE TREATMENT SITE. THE DEVICE WAS ABLE TO RUN FOR ABOUT A MINUTE AND THEN A CHECK SALINE SUPPLY ERROR OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN TRIED TO USE TWO OTHER ANGIOJET CATHETERS BUT THESE DEVICES WERE UNABLE TO COMPLETE THE PRIMING PROCESS OUTSIDE OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829502 ANGIOJET® SOLENT¿ PROXI CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - MAPLE GROVE 109676-001 19758378

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR