BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS EMBOLECTOMY CATHETER COMPONENT

    MDR report key: 1884242 · Received June 11, 2010

    Report

    Report Number
    3005789918-2010-00002
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    January 15, 2009
    Report Date
    March 18, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DXE
    PMA / PMN Number
    K902327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: TWO EMBOLECTOMY CATHETERS WERE RETURNED. THE STOPCOCKS WERE OBSERVED TO BE SEPARATED FROM THE EXTENSION LINE TUBING. VISUAL INSPECTION OF THE TUBING AND STOPCOCK INDICATE THAT THE EXTENSION LINE TUBING HAD PULLED OUT OF THE HUB. THE ARROW INTERNATIONAL DEVICE HISTORY RECORDS WERE REVIEWED WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE REPORTED COMPLAINT OF STOPCOCK SEPARATION WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE POTENTIAL CAUSE OF THIS ISSUE IS SUPPLIER RELATED SINCE THE CATHETER ASSEMBLY IS A PURCHASED ITEM. BASED ON THE INVESTIGATION OF SIMILAR COMPLAINTS, SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES OF MFR CONTROL NO. (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR # 3005789918-2009-00004, MDR # 3005789918-2010-00001. UNTIL (B)(6) 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6) 2009 THROUGH (B)(6) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6). PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE CATHETER BENT/BROKE NEAR THE LUER LOCK CONNECTION. ADD'L INFO RECEIVED FROM SALES REP ON (B)(6) 2009 STATED WHEN THE PHYSICIAN WAS PULLING BACK ON THE SYRINGE, THE LUER LOCK" POPPED OFF" THE END OF THE CATHETER. THERE WERE NO PT COMPLICATIONS REPORTED. NO FURTHER DETAILS OF THE EVENTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS EMBOLECTOMY CATHETER COMPONENT WALRUS PRODUCTS DXE ARROW INTERNATIONAL INC CF8109961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK