BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-SNARE

    MDR report key: 2508468 · Received March 26, 2012

    Report

    Report Number
    2032582-2012-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 26, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    DXE
    PMA / PMN Number
    K011783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PFM MEDICAL, INC. IS PROVIDING THE AGENCY WITH THIS INITIAL REPORT AS NOTIFICATION OF A REPORTABLE EVENT PER THE PFM COMPLAINT DECISION TREE. THE DEVICE INVOLVED WITH THE INCIDENT WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY UNDER INVESTIGATION. PFM MEDICAL, INC. SHALL PROVIDE THE AGENCY WITH A FOLLOW-UP REPORT ONCE THE COMPLAINT INVESTIGATION IS COMPLETE. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. VISUAL EXAMINATION. DEVICE BREAKAGE.

    Description of Event or Problem · 1

    THE CLIENT REPORTED TO PFM MEDICAL ON (B)(6) 2012 "PHYSICIAN WAS USING THE SNARE TO RETRIEVE A VENA CAVA FILTER WHEN THE SNARE BROKE. PHYSICIAN WAS ABLE TO REMOVE THE SNARE SAFELY WITHOUT ANY DETRIMENT TO THE PATIENT." ON (B)(6) 2012-"IN A CONVERSATION THE BIS SALES REP HAD WITH DR. (B)(6), THE PHYSICIAN SAID THE SNARE LOOKED LIKE IT UNRAVELED. THERE WAS CONCERN BY THE ACCOUNT THAT IT COULD HAVE FLOATED UPSTREAM. ACCOUNT IS UNSURE IF THEY WILL USE THE SNARE TO REMOVE A COOK FILTER AGAIN. ACCOUNT ALSO NOTED THAT WHEN THE HOOK ON THE FILTER WAS GRASPED, THE SNARE STRAIGHTENED THE HOOK. THE ACCOUNT IS THINKING IT COULD BE A PROBLEM WITH THE FILTER HOOK AND NOT THE SNARE." ON (B)(4) 2012-"IN A CONVERSATION THE BIS SALES REP HAD WITH DR. (B)(6), THE FILTER WAS PLACED BY ANOTHER HOSPITAL A COUPLE OF MONTHS AGO. DR. (B)(6) STATED THAT HE DID NOT HAVE TO PULL THAT HARD TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-SNARE CATHETER, EMBOLECTOMY DXE PFM MEDICAL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1