BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12.5 FR (4.2 MM) (.166 IN.) PEEL-AWAY CATHETER INTRODUCER

    MDR report key: 15431475 · Received September 15, 2022

    Report

    Report Number
    3014334038-2022-00205
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 10, 2022
    Report Date
    May 18, 2023
    Manufacturer
    RAYNHAM
    Product Code
    GYK
    UDI-DI
    10381780521402
    PMA / PMN Number
    K883607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CATHETER INTRODUCER (ID 831825) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED ; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED: "PATIENT WENT APNEIC AND DESATED. ¿PPV¿ STARTED AND THEN HEART RATE (HR) DROPPED BELOW 60 AND CHEST COMPRESSIONS STARTED. NEONATAL TEAM CALLED TO ROOM. AFTER VENTRICULOPERITONEAL (VP) SHUNT SURGERY PATIENT DEVELOPED PNEUMOPERITONEUM. THE PATIENT WAS TAKEN BACK TO OPERATING ROOM (OR) WHERE THE VP SHUNT WAS FOUND TO BE THROUGH ANTERIOR AND POSTERIOR WALL OF STOMACH AT LESSER CURVATURE, AND THROUGH TRANSVERSE COLONIC MESENTERY. THE SHUNT WAS REMOVED FROM THE STOMACH AND BOTH DEFECTS WERE OVER SEWN. THE 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."

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2741091 12.5 FR (4.2 MM) (.166 IN.) PEEL-AWAY CATHETER INTRODUCER CATHETER PASSERS AND INTRODUCERS GYK RAYNHAM 831325 5955073 10381780521402

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Female