BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 5051892 · Received September 2, 2015

    Report

    Report Number
    3004962788-2015-00063
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 5, 2015
    Report Date
    September 25, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPONENT OF THE SUPERDIMENSION SYSTEM WAS RETURNED AND EVALUATED AND NOTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S REPORT WAS FOUND. SITE REPORTED THAT PNEUMOTHORAX WAS RULED OUT. BLEEDING IS A KNOWN POTENTIAL COMPLICATION OF THE ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY PROCEDURE WHEN BIOPSIES ARE OBTAINED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED ANOTHER FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPONENT OF THE SUPERDIMENSION SYSTEM, CASE RECORDINGS, HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE AND THE GENCUT BIOPSY TOOL LOT. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SITE REPORTED PATIENT EXPERIENCED BLEEDING AFTER BIOPSIES DURING A SUPERDIMENSION PROCEDURE. THE CATHETER WAS REMOVED AND LARGE AMOUNT OF BLEEDING NOTED. PATIENT BRIEFLY ARRESTED BUT WAS SUCCESSFULLY RESUSCITATED AFTER PLACEMENT OF A RIGID SCOPE TO TAMPONADE THE BLEEDING AND INTUBATION. THE PATIENT WAS HOSPITALIZED BUT HAS SINCE BEEN DISCHARGED TO HOME. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581772 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| O| R