BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESHEATH HEMOSTATIC TEAR-AWAY INTRODUCER

    MDR report key: 2133470 · Received June 15, 2011

    Report

    Report Number
    2529252-2011-00006
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 22, 2011
    Report Date
    June 15, 2011
    Manufacturer
    THOMAS MEDICAL PRODUCTS
    Product Code
    DYB
    PMA / PMN Number
    K003731
    Removal / Correction Number
    Z-1225/8-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO (B)(6) PT INFO HAS NOT BEEN MADE AVAILABLE. THE PRODUCT WAS NOT RETURNED TO THE MFG SITE FOR INVESTIGATION. POUCH SAMPLES (N=30) FROM THE SAME LOT AS USED BY THIS SITE WERE TESTED IN-HOUSE AND FOUND TO BE WITHIN SPEC. THE SAFESHEATH WAS INVOLVED IN RECALL Z-1225/8-2011 WHICH HAS BEEN INITIATED AND WAS REPORTED TO FDA PER 21 CFR PART 806. THE EVENT OCCURRED IN EARLY (B)(6) 2011, THE FACILITY RECEIVED THE RECALL NOTIFICATION LATER IN 4/2011, AND THE COMPLAINT WAS REPORTED IN (B)(4) 2011.

    Description of Event or Problem · 1

    A USER REPORTED VIA A DISTRIBUTOR THAT SEVERAL DAYS AFTER THE IMPLANTING OF A CARDIAC RESYNCHRONIZATION THERAPY (CRT) HEART DEVICE, WHERE LEADS WERE PLACED WITH THE USE OF A SAFESHEATH INTRODUCER, THAT THE PT DEVELOPED PNEUMONIA AND SEPSIS. DUE TO THE BACTERIAL INFECTION THE PT WAS HOSPITALIZED FOR 10 ADD'L DAYS AND WAS TREATED WITH ANTIBIOTICS. THE PT'S OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESHEATH HEMOSTATIC TEAR-AWAY INTRODUCER CATHETER INTRODUCER DYB THOMAS MEDICAL PRODUCTS FCL-022-05 S32993

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R QUICKFLEX XL 1158/T 86CM, S/N (B)(4)| ARRROW BALLOON AI-07126, (B)(4)| CPS RESPONSE CATHETER (B)(4) LOT 3298436| DURATA LEAD 7120/65 CM, S/N (B)(4)| SJM GUIDERIGHT (B)(4), LOT 9902385| CPS-DIRECT PL (B)(4) LOT 31512975| OPTISENSE 1999/52 CM, S/N (B)(4)| ISSUES)| PROMOTE+ CD-3211-36 ICD, S/N (B)(4)| (WAS DISCARDED DURING SURGERY DUE TO PROCEDURAL| QUICKFLEX XL 1258/T 86CM, S/N (B)(4)| SURGERY ACCESSORIES| STERILE COVER