BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE R/O II INTRODUCER KIT

    MDR report key: 1594568 · Received February 3, 2010

    Report

    Report Number
    1118880-2010-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    December 14, 2009
    Report Date
    December 14, 2009
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K082847
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - BASED UPON RETURN SAMPLE EVAL; BASED ON QUALITY RECORD & RESERVE SAMPLE EVAL. CONCLUSION - BASED UPON RETURNED SAMPLE EVAL; BASED ON QUALITY RECORD & RESERVE SAMPLE EVAL. VISUAL EXAMINATION OF THE RETURNED SAMPLE DETERMINED THAT THE REPORTED FOREIGN BODY WAS THE DETACHED DISTAL TIP OF THE DILATOR. MAGNIFIED EXAMINATION REVEALED THAT THE EDGES OF THE DILATOR AT THE POINT OF SEPARATION HAD A STRAIGHT, SMOOTH SECTION ADJACENT TO A ROUGH, JAGGED SECTION. INSPECTION & TESTING OF RETAINED SAMPLES CONFIRMED THAT THERE WERE NO DEFECTS AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCT RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION AND THE RETURNED SAMPLE APPEARANCE ARE CONSISTENT WITH THE DILATOR HAVING BEEN PARTIALLY DAMAGED AS A RESULT ON CONTACT WITH A SHARP INSTRUMENT, SUCH AS A SCALPEL, AND THEN, PULLED DURING REMOVAL, RESULTING IN TEARING-OFF THE REMAINING ATTACHMENT POINT OF THE DILATOR TIP. THE OBSERVED DAMAGE & SEPARATION OF A PORTION OF THE DILATOR HAS NOT BEEN PREVIOUSLY REPORTED. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND F/U. (B) (4)

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING THE "POST PLACEMENT ROUTINE FLUSH," IT WAS NOTED THAT A "FOREIGN BODY" FLOWED FROM THE SHEATH HOUSING INTO THE SIDE ARM AND ENDED UP BEING ASPIRATED INTO THE FLUSH SYRINGE. SUBSEQUENTLY, THE FOREIGN BODY WAS RECOVERED WHEN THE SYRINGE WAS EMPTIED ONTO A TOWEL. REPORTEDLY, THERE WAS NO IMPACT TO THE PT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE R/O II INTRODUCER KIT DYB TERUMO MEDICAL CORP. NA LK05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK J-WIRE| MICRO SET