BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN

    MDR report key: 15300221 · Received August 26, 2022

    Report

    Report Number
    15300221
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    August 10, 2022
    Report Date
    August 19, 2022
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    GYK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WENT APENIC AND DESATED. PPV STARTED AND THEN HR DROPPED BELOW 60 AND CHEST COMPRESSIONS STARTED. NEONATAL TEAM CALLED TO ROOM. AFTER VENTRICULOPERITONEAL (VP) SHUNT SURGERY PATIENT DEVELOPED PNEUMOPERITONEUM. PATIENT TAKEN BACK TO OR WHERE THE VP SHUNT WAS FOUND TO BE THROUGH ANTERIOR AND POSTERIOR WALL OF STOMACH AT LESSER CURVATURE, AND THROUGH TRANSVERSE COLONIC MESENTERY. SHUNT REMOVED FROM STOMACH AND BOTH DEFECTS OVER SEWN. PATIENT HAD RETURNED FROM THE OR APPROXIMATELY 30 MINUTES PRIOR TO EVENT. TRANSITIONED TO NC (NASAL CANNULA), THEN WENT APNEIC. CODMAN SPLIT SHEATH TROCAR WENT THROUGH ANTERIOR AND POSTERIOR WALLS OF THE STOMACH. THE CATHETER INTRODUCER USED WAS THE SMALLER SIZE 12.5 FR. REF# 83-1325, LOT# 5955073 THIS DEVICE WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481803 CODMAN INSTRUMENT, SHUNT SYSTEM IMPLANTATION GYK INTEGRA LIFESCIENCES PRODUCTION CORPORATION 831325 5955073

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Female