BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE VENTING SPRAY CRYOTHERAPY TRUFREEZE RAPID AV CATHETER KIT WITH 16 FR CDT

    MDR report key: 8703611 · Received June 14, 2019

    Report

    Report Number
    MW5087382
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 12, 2019
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) MALE PRESENTED FOR SPRAY CRYOABLATION OF GE JUNCTION ADENOCARCINOMA. THE 16 FR DECOMPRESSION TUBE WAS SUCCESSFULLY PLACED ENDOSCOPICALLY AND AS SOON AS THE SPRAY CRYOTHERAPY WAS STARTED, THE PT HAD FULL THICKNESS GASTRIC PERFORATION WITHIN 5 SECONDS OF TREATMENT. THE CRYOTHERAPY WAS STOPPED AND THE DECOMPRESSION TUBE WAS REMOVED. RELOOK EXAM SHOWED A FULL THICKNESS PERFORATION ON THE LESSER CURVATURE OF THE PROXIMAL GASTRIC BODY AND PT DEVELOPED A PNEUMOPERITONEUM. AN ANGIOCATH WAS PLACED IN THE EPIGASTRIC AREA FOR DECOMPRESSION OF THE PNEUMOPERITONEUM. AN ENDOSCOPIC SUTURING DEVICE WAS USED AT THE SAME TIME TO CLOSE THE DEFECT ENDOSCOPICALLY, WHICH WAS SUCCESSFUL. THE PT WAS ADMITTED TO ICU AND UPPER GI SERIES DID NOT SHOW ANY ACTIVE LEAK AFTER ENDOSCOPIC CLOSURE. THE PT REQUIRED 2 WEEKS OF INPATIENT RECOVERY DUE TO ABDOMINAL PAIN AND INTOLERANCE TO DIET, AND WAS EVENTUALLY DISCHARGED TO NURSING HOME FOR COMFORT CARE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495641 ACTIVE VENTING SPRAY CRYOTHERAPY TRUFREEZE RAPID AV CATHETER KIT WITH 16 FR CDT UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R