BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR

    MDR report key: 13518955 · Received February 11, 2022

    Report

    Report Number
    9611594-2022-00012
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    August 12, 2021
    Report Date
    April 8, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984339
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 10-FEB-2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30106553, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 08-APR-2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4). THE FOLLOWING INFORMATION: DURING CT (COMPUTED TOMOGRAPHY) GUIDED IR (INTERVENTIONAL RADIOLOGY) PERCUTANEOUS GASTROSTOMY TUBE PLACEMENT, A SEGMENTED TELESCOPING DILATOR AND PEEL-AWAY SHEATH WAS THEN ADVANCED OVER THE WIRE AT THE CENTRAL ACCESS POINT AND DILATION WAS PERFORMED. THEN REMOVED; THIS REQUIRED GREATER THAN EXPECTED FORCE WHICH WAS THOUGHT TO BE DUE TO KINKING OF THE WIRE FOR DILATOR. WE THEN TRIED TO ADVANCE AN 18 FRENCH GASTROSTOMY TUBE INTO THE PEEL­ AWAY SHEATH WITHOUT SUCCESS. IT WAS SUBSEQUENTLY NOTED THAT A PORTION OF THE TELESCOPING DILATOR WAS STILL SITUATED WITHIN THE PEEL-AWAY SHEATH, THIS WAS GRASPED AND REMOVED WITH HEMOSTATS. THE TUBE WAS THEN SUCCESSFULLY PLACED THROUGH THE PEEL-AWAY SHEATH WHICH WAS THEN PEELED AND WITHDRAWN. AT THIS POINT, THE TECHNOLOGIST NOTED THAT AN ADDITIONAL PORTION OF THE TELESCOPING DILATOR WAS NOT ON THE PROCEDURE TRAY WE RESCANNED THE PATIENT WHICH DEMONSTRATED THE GASTROSTOMY TUBE WITH INFLATED BALLOON IN APPROPRIATE POSITION AND A SUBTLE RADIOLUCENT STRUCTURE WITHIN THE GASTRIC ANTRUM CORRESPONDING TO THE MISSING PORTION OF THE TELESCOPING DILATOR. WE CONTACTED THE ON-CALL GI (GASTRO-INTESTINAL) DOCTOR FOR ENDOSCOPIC RETRIEVAL OF THIS FOREIGN BODY. THE PATIENT WAS TAKEN TO OR (OPERATING ROOM) AND HAD THE FOREIGN BODY SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119417 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98433 30106553 00350770984339

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention