BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION CAROTID GUIDING SHEATH

    MDR report key: 1923337 · Received November 2, 2010

    Report

    Report Number
    1118880-2010-00020
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K052185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ALTHOUGH THERE WAS REPORTEDLY NO IMPACT TO THE PATIENT, THE EVENT DESCRIPTION INDICATES THAT BLOOD LOSS DID OCCUR - (B)(4): RESULTS: BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; BASED UPON RESERVE SAMPLE EVALUATION. CONCLUSIONS: BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; BASED UPON RESERVE SAMPLE EVALUATION. THE RETURNED SAMPLE FROM THE CUSTOMER INCLUDED THE "Y-BODY" SECTION OF THE TUOHY-BORST HEMOSTATIC VALVE WITHOUT THE O-RING OR LUER COLLAR. INSPECTION OF THE Y-BODY DID NOT INDICATE ANY DAMAGE OR OTHER ANOMALIES. INSPECTION AND TESTING OF REPRESENTATIVE RETAINED SAMPLES FROM THE REPORTED, PREVIOUS & SUBSEQUENT LOTS FOUND NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. THERE WERE NO INDICATIONS OF ANY PRODUCTION RELATED PROBLEMS IN THE DEVICE HISTORY RECORDS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. WHILE THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION IS CONSISTENT WITH OVER-PRESSURIZATION DURING THE POWER ASSISTED INJECTION. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE CAUTIONS SECTIONS OF THE DEVICE INSTRUCTIONS-FOR-USE LABELING BY STATING, "DO NOT USE A POWER INJECTOR THROUGH THE SIDE TUBE AND 3-WAY STOPCOCK. IF RAPID INJECTIONS ARE REQUIRED, REMOVE... VALVE AND INJECT DIRECTLY THROUGH THE SHEATH HUB." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE HEMOSTATIC VALVE "POPPED OFF" OF THE SHEATH WHEN USING A POWER INJECTOR DURING A PROCEDURE. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT: THE PRIMARY PROCEDURE WAS THE REPAIR OF A TYPE-1 ENDOLEAK WITH AORTIC CUFF X 2"; A POWER INJECTOR WAS BEING USED TO INJECT THROUGH THE SIDE TUBE & 3-WAY STOPCOCK AT A SETTING OF 600-PSI; THE TUOHY-BORST HEMOSTATIC VALVE WAS DISLODGED FROM THE PROXIMAL END OF THE GUIDING SHEATH RESULTING IN APPROXIMATELY 200-CC BLOOD LOSS FOR THE PATIENT; THE INVOLVED DEVICE WAS REPLACED WITH A SECOND GUIDING SHEATH & THE PROCEDURE WAS SUCCESSFULLY COMPLETED; THE PATIENT WAS ADMITTED & RELEASED FROM THE HOSPITAL ON THE SAME DAY IN STABLE CONDITION FOLLOWING THE PROCEDURE; & UF MEDWATCH # (B)(4) WAS SUBMITTED AS A PRECAUTIONARY MEASURE, BUT A COPY WAS NOT PROVIDED UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE DESTINATION CAROTID GUIDING SHEATH DYB TERUMO MEDICAL CORP. NA LM28

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEDRAD MARK V PROVIS POWER INJECTOR