BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT BRIDLE

    MDR report key: 11477459 · Received March 12, 2021

    Report

    Report Number
    1526012-2021-00008
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Report Date
    March 12, 2021
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K142971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO AN EVENT FOUND IN AN INTERNAL LITERATURE REVIEW. WE HAVE ASSIGNED COMPLAINT # (B)(4) TO THIS REPORT. BASED ON THE REPORTED INFORMATION, THERE WAS NO DEATH NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR A SERIOUS INJURY THAT IS LIFE-THREATENING, AS DEFINED BY THE FDA. ALTHOUGH THERE WAS NO PATIENT HARM IN THIS CASE AND THERE IS NO CHANCE OF DEATH OR SERIOUS INJURY, ADDITIONAL INTERVENTION WAS REQUIRED, THUS THIS RECORD IS BEING REPORTED. AMT IS WORKING ON CONTACTING THE INITIAL REPORTER TO SEE IF THE DEVICE IS AVAILABLE FOR EXAMINATION. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS FOUND DOCUMENTED IN THE FOLLOWING ARTICLE INAYAT F, UR RAHMAN A, ALMAS T, ET AL. (MAY 28, 2020) NASAL BRIDLES FOR SECURING NASOENTERIC FEEDING TUBES: A REVIEW OF CLINICAL EFFECTIVENESS AND POTENTIAL COMPLICATIONS. CUREUS 12(5): E8325. DOI 10.7759/CUREUS.8325. THE OCCURRENCE REPORTED THE FOLLOWING: "A (B)(6)-YEAR-OLD FEMALE UNDERWENT AN UNEVENTFUL SIMULTANEOUS LIVER-KIDNEY TRANSPLANTATION 10 DAYS PRIOR TO THE CURRENT PRESENTATION. HER MEDICAL HISTORY INCLUDED STEATOHEPATITIS-RELATED CIRRHOSIS AND CHRONIC RENAL INSUFFICIENCY FOLLOWING DIABETIC NEPHROPATHY. OWING TO HER SIGNIFICANT BASELINE FRAILTY, THE PATIENT SHOWED A PROLONGED POSTOPERATIVE RECOVERY. SHE CONTINUED TO HAVE A POOR APPETITE AND FLUCTUATING MENTATION AFTER THE SURGERY. A NASOENTERIC TUBE WAS THUS PLACED THROUGH THE LEFT NOSTRIL TO AMELIORATE THE CALORIC DEFICIT. AFTER THE PROCEDURE, MAGNETIC NASAL BRIDLE (AMT BRIDLE, APPLIED MEDICAL TECHNOLOGY, BRECKSVILLE, OH, USA) INSERTION WAS ATTEMPTED. HOWEVER, SHE BECAME EXTREMELY AGITATED DURING THE BRIDLE PLACEMENT AND INTERMAGNETIC LINKAGE COULD NOT BE ACHIEVED. UPON REMOVAL OF THE PROBE, IT WAS NOTED THAT THE MAGNET WAS MISSING FROM ITS DISTAL END. THE OTORHINOLARYNGOLOGY SERVICE WAS CONSULTED. AN URGENT NASAL ENDOSCOPY WAS PERFORMED, BUT THE MAGNET COULD NOT BE VISUALIZED. A PLAIN RADIOGRAPH OF THE PARANASAL SINUSES SHOWED A RADIOPAQUE OBJECT LODGED AT THE SPHENOID OS. A MULTIDISCIPLINARY TEAM PLANNED A CT-GUIDED ENDOSCOPIC SINUS SURGERY. THE SURGICAL INTERVENTION RESULTED IN THE SUCCESSFUL RETRIEVAL OF THE MAGNET. THEREAFTER, SHE COMPLETELY RECOVERED WITHOUT THE NEED FOR A PERCUTANEOUS GASTROSTOMY TUBE (PEG) PLACEMENT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375449 AMT BRIDLE BRIDLE NASAL RETAINING SYSTEM KNT APPLIED MEDICAL TECHNOLOGY, INC. 4-XXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other