BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMA-G SYSTEM

    MDR report key: 21527977 · Received March 5, 2025

    Report

    Report Number
    3015177732-2025-00001
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 3, 2025
    Report Date
    March 5, 2025
    Manufacturer
    COAPTECH, INC.
    Product Code
    KGC
    PMA / PMN Number
    K223916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILED DEVICE WAS DISCARDED BY THE CUSTOMER DESPITE A VERBAL REQUEST TO RETAIN IT. AN INVESTIGATION WAS CONDUCTED, INCLUDING REVIEW OF FAILURE TESTING AND PRODUCTION INFORMATION FROM THE GUIDEWIRE SUPPLIER, FORCE TESTING OF THE SPRING WIRE TO FAILURE, AND AN INVESTIGATION COMPLETED BY THE GUIDEWIRE SUPPLIER WITH TEST DATA FROM THE RETAINS OF THE SUSPECTED LOT. ALTHOUGH NO CONFIRMATORY CONCLUSION CAN BE DRAWN FROM THE AVAILABLE INFORMATION, THE FOLLOWING SCENARIOS ARE A POSSIBILITY: (A) THE WELD BINDING THE SPRING WIRE AND CORE WIRE TOGETHER AT THE PIGTAIL END COULD HAVE FAILED AS THE DOCTOR ATTEMPTED TO RETRACT THE PGW FROM THE ABDOMEN. THIS CAUSED THE CORE WIRE AND SPRING WIRE TO BE INDIVIDUAL PIECES WHERE THE DOCTOR WAS ABLE TO RETRIEVE ALL THE CORE WIRE, BUT AS THE DOCTOR CONTINUED TO PULL ON THE SPRING WIRE, IT FRACTURED, LEAVING A PORTION OF THE WIRE IN THE PATIENT. (B) THE SPRING WIRE OF THE GUIDEWIRE COULD HAVE BECOME ANCHORED UPON A PIECE OF TISSUE AND AS THE DOCTOR TRIED TO RETRACT THE PGW, THE CAUGHT PORTION OF THE SPRING WIRE BEGAN STACK UP ON ITSELF WHILE THE PORTION BEING REMOVED UNRAVELED. THE UNRAVELING SPRING WIRE THEN WAS ABLE TO FRACTURE WITH LITTLE FORCE WHILE AT THE SAME TIME, THE WIRE STACKING UP ON ITSELF ALSO FRACTURED. THIS WOULD LEAVE A PORTION OF THE SPRING WIRE IN THE PATIENT WHILE THE REST OF THE WIRE WOULD BE ABLE TO BE REMOVED.

    Description of Event or Problem · 0

    DURING THE PUG (PERCUTANEOUS ULTRASOUND GASTROSTOMY) PROCEDURE, THE USER ADVANCED THE PGW (PIGTAIL GUIDEWIRE) AND IBC (INTERNAL BALLOON CATHETER) AFTER SUSPECTED COUPLING, BUT THE IBC EMERGED FROM THE MOUTH WITHOUT THE PGW. AT THAT POINT, THEY ATTEMPTED TO PULL THE PGW FROM THE ABDOMINAL PUG SITE AND FELT RESISTANCE. WITH ADDITIONAL FORCE, THE PGW WAS ABLE TO BE REMOVED FROM THE PATIENT'S ABDOMEN. HOWEVER, IT APPEARED THAT A PIECE OF THE OUTER COIL OF THE PGW DISTAL TIP HAD BROKEN OFF AND WAS LIKELY STILL INSIDE THE PATIENT. A RADIOGRAPHIC EXAM (KUB) WAS PERFORMED, WHICH INDICATED THE PRESENCE OF A METALLIC FOREIGN BODY INSIDE THE ABDOMEN, BUT THE EXACT LOCATION WAS UNCLEAR. IN THE DAYS FOLLOWING THE PUG PROCEDURE, KUB, CT IMAGING, AND RADIOLOGIC IMAGING WERE COMPLETED TO CONFIRM THE WIRE SEGMENT AND GENERAL LOCATION WITHIN THE PATIENT'S ABDOMEN. ON (B)(6) 2025, A LAPAROTOMY WAS SUCCESSFULLY COMPLETED, REMOVING A COILED WIRE SEGMENT FROM THE PGW'S DISTAL TIP THAT WAS WITHIN THE PREPERITONEAL SPACE. THE SURGICAL TEAM PLACED A GASTROSTOMY TUBE. SURGEONS NOTED THERE WERE NO SIGNS OF OTHER COMPLICATIONS FROM THE PUG PROCEDURE. POST-SURGICAL X-RAY CONFIRMED REMOVAL OF THE ENTIRE WIRE SEGMENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479950 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 00100046

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention