BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 6403844 · Received March 14, 2017

    Report

    Report Number
    3010757606-2017-00136
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 2, 2017
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062943-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN MODEL #/LOT # WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED, IT REMAINS IMPLANTED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A PERFORATION IS A KNOWN COMPLICATION OF A PEGJ TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD: (B)(4). IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR A RE-PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL (PEG-J)TUBE. DURING ENDOSCOPIC PROCEDURE TO REPLACE THE PEG/PEJ SYSTEM ABBVIE20, THE DUODENAL PROBE PIERCED THE GASTRIC WALL CREATING THE FISTULA SO THAT IT IS IMPOSSIBLE TO RETRACT AND REMOVE THE PROBE ITSELF. THE PATIENT WAS TO UNDERGO SURGERY TO RESOLVE THE PROBLEM.

    Description of Event or Problem · 1

    DURING ENDOSCOPIC PROCEDURE THE DOCTOR OBSERVED THE JEJUNAL PROBE TOP WAS POSITIONED AT THE TRANSVERSAL LEVEL. THE PROBE HAD CREATED A SETON EFFECT ON THE STOMACH, DUODENUM AND SOME JEJUNAL LOOPS. THE PROBE ENTERED THE GASTRIC WALL AT THE PRE-PYLORIC LEVEL. THE DOCTOR HAS SEPARATED THE STOMACH AND INTESTINAL WALL AT THE PEG LEVEL. DURING THE GASTROSCOPY A BEZOAR WAS OBSERVED ON THE TIP OF THE PEJ THAT CONTRIBUTED TO A GASTRIC WALL INJURY, THE PERFORATION OF 3 INTESTINAL LIMBS WITH THE ULTIMATE ENDPOINT OF THE TRANSVERSE COLON TIP. THE PEG AND PEJ WERE REMOVED AND THE AFFECTED INTESTINAL TRACT AFFECTED BY SUTURE POINTS WITHOUT THE INTESTINAL LIMBS BEING EXPORTED. ON AN UNKNOWN DATE THE PATIENT REQUIRED ANOTHER SURGERY FOR UNSPECIFIED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186337 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ABBVIE PEG UNKNOWN LOT