BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT

    MDR report key: 12206873 · Received July 21, 2021

    Report

    Report Number
    1317056-2021-00130
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    July 1, 2019
    Report Date
    September 29, 2021
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    UDI-DI
    H787CT80STPDVI1
    PMA / PMN Number
    K101017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF FRACTURE OF THE CATHETER TUBING COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. IF CATHETER WAS PLACED SUB-CLAVIAN THEN PINCH-OFF SYNDROME IS POTENTIAL ROOT CAUSE FOR CATHETER FRACTURE. LABELING REVIEW: THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE USER WITH THIS ITEM NUMBER, CONTAINS THE FOLLOWING STATEMENTS: ABSENCE OF A BLOOD RETURN OR A POOR BLOOD RETURN CAN BE A SIGN OF A POTENTIAL COMPLICATION SUCH AS OCCLUSION, KINKING, BREAKAGE, PINCH-OFF SYNDROME, FIBRIN FORMATION, THROMBOSIS OR MALPOSITION. THIS SHOULD BE EVALUATED PRIOR TO DEVICE USAGE. A BLOOD RETURN SHOULD BE PRESENT PRIOR TO USAGE OF DEVICE FOR ANY THERAPY OR TESTING. IF THE PATIENT COMPLAINS OF PAIN, OR IF THERE IS SWELLING WHEN THE DEVICE IS FLUSHED OR WHEN MEDICATION OR CONTRAST MEDIA IS ADMINISTERED, EVALUATE THE DEVICE FOR INFILTRATION, PROPER NEEDLE PLACEMENT, AND POTENTIAL COMPLICATIONS SUCH AS OCCLUSION, KINKING, BREAKAGE, PINCH-OFF SYNDROME, THROMBOSIS OR MALPOSITION. FAILURE TO ASSESS THESE COMPLAINTS OR OBSERVATIONS CAN LEAD TO DEVICE FAILURE. CAUTION: AVOID PIERCING CATHETER WITH SUTURE NEEDLE. POTENTIAL COMPLICATIONS: CATHETER FRAGMENTATION AND CATHETER PINCH-OFF. CATHETER PLACEMENT CONSIDERATIONS: WARNING: AVOID MEDIAL CATHETER PLACEMENT INTO SUBCLAVIAN VEIN THROUGH PERCUTANEOUS TECHNIQUE. THIS PLACEMENT COULD LEAD TO CATHETER OCCLUSION, DAMAGE, RUPTURE, SHEARING, OR FRAGMENTATION DUE TO COMPRESSION OF THE CATHETER BETWEEN THE FIRST RIB AND CLAVICLE. CATHETER SHEARING HAS BEEN REPORTED WHEN THE CATHETER IS INSERTED VIA A MORE MEDIAL ROUTE IN THE SUBCLAVIAN VEIN. TO AVERT DEVICE DAMAGE AND/OR PATIENT INJURY DURING CATHETER PLACEMENT: AVOID ACCIDENTAL DEVICE CONTACT WITH SHARP INSTRUMENT AND MECHANICAL DAMAGE TO THE CATHETER MATERIAL. USE ONLY SMOOTH-EDGED ATRAUMATIC CLAMPS OR FORCEPS. DO NOT USE THE CATHETER IF THERE IS ANY EVIDENCE OF MECHANICAL DAMAGE OR LEAKING. AVOID SHARP OR ACUTE ANGLES DURING IMPLANTATION WHICH COULD COMPROMISE THE PATENCY OF THE CATHETER LUMEN(S). CAREFULLY FOLLOW THE CONNECTION TECHNIQUE GIVEN IN THESE INSTRUCTIONS TO INSURE PROPER CATHETER CONNECTION AND TO AVOID CATHETER DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE: (B)(4).

    Description of Event or Problem · 1

    ANGIODYNAMICS, INC. RECEIVED A LEGAL SUMMONS FROM A PLAINTIFF WHO CLAIMS THEIR CT W/8FR DET POLY CATH W/VI SMARTPORT PG CAUSED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AS WELL AS PRESENT AND FUTURE LOST WAGES. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100158 SMART PORT PORT & CATHETER, LJT ANGIODYNAMICS CT80STPD-VI 5420436 H787CT80STPDVI1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S