BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / VORTEX

    MDR report key: 6930741 · Received October 9, 2017

    Report

    Report Number
    1056436-2017-00105
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 19, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    UDI-DI
    H787LVTX52130
    PMA / PMN Number
    K010767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR ITEM NUMBER (B)(4) IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTING HOSPITAL IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE SHR INDICATED THE REPORTING HOSPITAL ONLY RECEIVED {TWO LOTS} OF THIS ITEM NUMBER IN THE SIX MONTHS PRIOR TO THE PROCEDURE. THE DEVICE HISTORY RECORDS FOR THE LOTS OBTAINED THROUGH THE SHIP HISTORY REPORT (PACKAGING LOTS) WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE VORTEX PORT PRODUCT FAMILY AND THE FAILURE MODE "DEVICE MALFUNCTIONED - REMOVED." NO ADVERSE TREND WAS INDICATED. AS RECEIVED, THE PORT CONTAINED BIO MATERIAL INSIDE AND OUT. THE CATHETER TUBING WAS FRACTURED ABOUT 1 CM FROM THE PORT. WHEN THE SHORT PIECE OF CATHETER ATTACHED TO THE PORT WAS CLAMPED OFF AND PRESSURIZED WITH AIR, A LEAK WAS DETECTED. AFTER THE BAYONET LOCKING MECHANISM WAS REMOVED A HOLE WAS OBSERVED IN THE OUTER WALL OF THE CATHETER. DIMENSIONAL CHECK: DIMENSIONAL CHECK: PER CATHETER TUBING DRAWING (B)(4) THE FOLLOWING DIMENSIONS WERE VERIFIED USING PIN GAUGES (QA87): - ID LUMEN 1: MEASURED .051", SAMPLE MET SPECIFICATION OF .050±.003". - ID LUMEN 2: MEASURED .051", SAMPLE MET SPECIFICATION OF .050±.003". - OD: MEASURED .151", SAMPLE MET SPECIFICATION OF .149±.002". DIMENSIONAL CHECK: PER MALE STEM DRAWING 101347 (REV. K) THE FOLLOWING DIMENSIONS WERE VERIFIED USING ((B)(4)): - OD 1: MEASURED .062", SAMPLE MET SPECIFICATION OF .062±.001". - OD 2: MEASURED .062", SAMPLE MET SPECIFICATION OF .062±.001". DIMENSIONAL CHECK: PER CATHETER CONNECTOR DUAL PORT (BAYONET LOCKING MECHANISM) DRAWING (B)(4) THE FOLLOWING DIMENSION WAS VERIFIED USING PIN GAUGES (QA26): - ID: MEASURED .153", SAMPLE MET SPECIFICATION OF .153±.001". THE HOSPITAL'S COMPLAINT DESCRIPTION OF CATHETER RECIRCULATION COULD NOT BE CONFIRMED, NOR COULD AN EXACT ROOT CAUSE FOR THE CATHETER HOLE BE DETERMINED. (B)(6) (THE HOSPITAL APHERESIS PROGRAM COORDINATOR) AND DR. (B)(6) VERBALIZED THAT THE FIBRIN SHEATH MAY HAVE BEEN THE CAUSE FOR RECIRCULATION DURING APHERESIS. ADDITIONALLY, THE INDICATIONS FOR USE PROVIDED WITH THE DUAL LUMEN PORT DO NOT INDICATE APHERSIS BLOOD RE-CIRCULATION. THE USE OF THE PORT FOR THIS TYPE OF TREATMENT MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE DAMAGE / HOLE NOTED IN THE CATHETER. (B)(4)

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT UPON EXPLANTATION OF THE PORT/CATHETER, THE DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY HOSPITAL REGARDING A PATIENT WITH AN ANGIODYNAMICS VORTEX PORT: DURING RED CELL EXCHANGE/ APHERESIS RECIRCULATION OF BLOOD NOTED. THIS WAS THE THIRD RBCX SINCE PLACEMENT AND RECIRCULATION OCCURRED WITH EACH ATTEMPT. THE FIRST 2 TX'S WER SUCCESSFUL AFTER TPA PRIOR TO 1 HOUR. THE 3RD ATTEMPT/ TREATMENT SHOWED CLEAR RECIRCULATION. DYE STUDIES PERFORMED AFTER 2ND RBCX CIRCULATION AND IMPRESSION WAS A FIBRIN SHEATH. TX SUCCESSFUL AFTER TPA INSTILLED. IR HAS BEEN NOTIFIED WHEN 1ST TX WAS UNSUCCESSFUL, DX FIRBIN SHEATH, TPA INSTILLED AND SUCCESSFUL AFTER DECLOTTED. DECISION MADE AFTER HX OF FIBRIN SHEATH TO TPA PRIOR TO EXCHANGES HOWEVER TPA NOT EFFECTIVE AND RECIRCULATION DURING ENTIRE TREATMENT. PORT HAD BEEN ORIGINALLY IMPLANTED ON (B)(6) 2017. IT IS SCHEDULED TO BE REMOVED AND REPLACED ON (B)(6) 2017 AT WHICH TIME IT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. PER THE COMPLAINT REPORTER, NO SERIOUS INJURY RESULTED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711177 ANGIODYNAMICS / VORTEX PORT & CATHETER, IMPLANTED LJT ANGIODYNAMICS H787LVTX52130

    Patients

    Seq Age Sex Outcome Treatment
    1