BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-ACCESS TEARAWAY INTRODUCER KIT

    MDR report key: 16358063 · Received February 10, 2023

    Report

    Report Number
    1649395-2023-00002
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    December 26, 2022
    Report Date
    February 10, 2023
    Manufacturer
    GALT MEDICAL CORP
    Product Code
    OFL
    UDI-DI
    10841268105130
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE WILL NOT BE RETURNED BY DISTRIBUTOR OR END USER. INVESTIGATION AND EVALUATION PERFORMED BASED ON DEVICE HISTORY RECORD REVIEW, COMPLAINT HISTORY RECORD REVIEW, FAILURE MODE AND EFFECTIVE ANALYSIS REVIEW, RISK MANAGEMENT REPORT FOR RELATED PRODUCT FAMILY REVIEW. DEVICE HISTORY RECORD REVIEWED FOR MAIN PRODUCT AND SUBCOMPONENTS AND FOUND ALL PRODUCTS MANUFACTURED TO SPECIFICATION WITHOUT ANY DEVIATION OR ABNORMALITY INDICATED. COMPLAINT HISTORY RECORD REVIEWED AND FOUND THERE ARE NO COMPLAINTS FROM THE FIELD AGAINST SUBJECT DEVICE KIT-010-04 LAST FIVE YEARS. COMPLAINT HISTORY RECORD REVIEWED AND FOUND THERE ARE 59 RECORDS RECEIVED FROM CUSTOMER AND/OR END USER REGARDING FAILURE CATEGORY (BUCKLE TIP OF THE SHEATH). 16 RECORDS SHOW SAMPLES RETURNED AND COMPLAINT CONFIRMED. OTHER RECORDS SHOW COMPLAINED UNCONFIRMED DUE TO UNAVAILABILITY OF COMPLAINT SAMPLES. NONE OF 16 COMPLAINTS PREVIOUSLY RECEIVED HAS BROKEN TIPS. EVALUATION ON PREVIOUS COMPLAINTS SHOWS ROOT CAUSE OF THE INCIDENT WAS END USER ERROR AS MAJORITY OF THE UNITS SOLD AS BULK NON-STERILE. SUBJECT DEVICE IN THIS REPORT SOLD AS STERILE PRODUCT. END USER WILL BE NOTIFY TO ADHERE TO IFU.

    Description of Event or Problem · 0

    GALT MEDICAL CORPORATION RECEIVED MEDWATCH 3500A FORM REPORT FROM FDA BY EMAIL UNDER TITLE MDR REPORT: (B)(4). DESCRIPTION OF THE PROBLEM STATED (RN WAS PLACING A NEW POLY MIDLINE. AFTER ACCESSING THE VEIN AND THREADING THE GUIDEWIRE, RN ATTEMPTED TO INSERT A DROP IN GALT INTRODUCER. A SMALL NICK WAS MADE PRIOR TO ATTEMPTING TO PLACE DILATOR/INTRODUCER, HOWEVER, DESPITE SUFFICIENT NICK IN SKIN, THE INTRODUCER WOULD NOT ADVANCE PAST THE PEEL-ABLE SHEATH. ADDITIONAL SMALL NICK MADE, AND DILATOR/INTRODUCER ATTEMPTED AGAIN, BUT STILL UNABLE TO ADVANCE PAST PEEL-ABLE SHEATH. INTRODUCER REMOVED AGAIN AND INSPECTED FOR DEFECT. UPON INSPECTION, SHEATH NOTED TO HAVE DEFECT AND WAS CURLED AND/OR PEELED BACK AT THE TIP. AS A RESULT, THE PATIENT EXPERIENCED MILD PAIN/DISCOMFORT AND MILD/MODERATE AMOUNT OF BLOOD LOSS. A CELOX PATCH WAS PLACED, AND PRESSURE HELD AT SITE FOR APPROXIMATELY 5 MINUTES BEFORE DRESSING APPLIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47591 MICRO-ACCESS TEARAWAY INTRODUCER KIT PERCUTANEOUS SHEATH INTRODUCER KIT OFL GALT MEDICAL CORP KIT-010-14 S22356809 10841268105130

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other