BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SINGLE ELECTRODE PROBE, 15CM

    MDR report key: 6016434 · Received October 11, 2016

    Report

    Report Number
    1319211-2016-00140
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 12, 2016
    Report Date
    March 22, 2017
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    OAB
    UDI-DI
    H787204001015
    PMA / PMN Number
    K060054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4). DEVICE UNAVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS NOT TO REPORT A DEVICE MALFUNCTION, BUT AN ADVERSE PATIENT EVENT. THERE WAS NO REPORTED MALFUNCTION OF THE NANOKNIFE SYSTEM (GENERATOR AND PROBE,). NO PART OF THE SYSTEM WAS RETURNED FOR EVALUATION. AS AN EVALUATION OF THE ASSOCIATED DISPOSABLE DEVICE OR THE ASSOCIATED IRE UNIT WAS NOT PERFORMED, THE CUSTOMERS REPORTED COMPLAINT OF BLEEDING, 6-7 WEEKS POST PERCUTANEOUS IRE TREATMENT COULD NOT BE CONFIRMED. THOUGH THE COMPLAINT COULD NOT BE CONFIRMED, THE MOST LIKELY CAUSE TO POST TREATMENT BLEEDING IS DUE TO A PATIENT ISSUE. IT IS UNKNOWN IF THE PATIENT HAD ANY OTHER HEALTH CONDITIONS THAT COULD AFFECT THE IRE TREATMENT OR THE HEALING PROCESS. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE AND THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE NANOKNIFE GENERATOR USER MANUAL (160-105261) STATES THAT PATIENTS MAY BE AT RISK WITH INSUFFICIENT MUSCLE BLOCKADE OR ANESTHETIC ANALGESIA (REFLEX TACHYCARDIA AND REFLEX HYPERTENSION); PATIENTS WITH ABNORMAL SINUS RHYTHM PRIOR TO AN ABLATION (ARRHYTHMIA); PATIENTS WITH A HISTORY OF HYPERTENSION (HYPERTENSION); OR PATIENTS WITH PARTIAL PORTAL VENOUS THROMBOSIS, LOW CENTRAL VENOUS PRESSURE (CVP), AND A PROTHROMBOTIC CONDITION (VENOUS THROMBOSIS). A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(6) 2016, ON (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER HAD PRESENTED FOR AN IRE (IRREVERSIBLE ELECTROPORATION) PROCEDURE OF THE PANCREAS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF COMPLICATIONS OR DEVICE MALFUNCTIONS, INCLUDING A GOOD IMMEDIATE POST CT SCAN. IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS POST PROCEDURE, VIA A CT SCAN, THE TREATING PHYSICIAN NOTED A "NECROTIC AREA AND SOME GAS BUBBLES" AT THE ABLATION SITE. AT APPROXIMATELY 6-7 WEEKS POST PROCEDURE, IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A GI BLEED FROM THE GBD (GASTRODUODENAL ARTERY) WHICH RUNS THROUGH THE ABLATION SITE. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION AS TO THE PATIENT'S WELL BEING IN REGARDS TO THE EVENT. IT WAS REPORTED THE DISPOSABLE NANOKNIFE PROBE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668456 NANOKNIFE SINGLE ELECTRODE PROBE, 15CM LOW ENERGY DIRECT CURRENT ABLATION DEVICE OAB ANGIODYNAMICS, INC. H787204001015 H787204001015

    Patients

    Seq Age Sex Outcome Treatment
    1