BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 3043562 · Received April 9, 2013

    Report

    Report Number
    1118880-2013-00017
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 5, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K954234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE PHOTO OF THE INVOLVED SAMPLE, THE TIP OF THE DEVICE WAS DAMAGED DURING ATTEMPTED INSERTION INTO THE PATIENT; (B)(4) IS BASED UPON TESTING OF RESERVE SAMPLES CONCLUSIONS - (B)(4) IS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE PHOTO OF THE INVOLVED SAMPLE; (B)(4) IS BASED UPON TESTING OF RESERVE SAMPLES COMMUNICATION WITH THE USER FACILITY INDICATED THAT IT IS HOSPITAL POLICY NOT TO RETURN DEVICES TO THE MANUFACTURER. THEREFORE, THE INVOLVED DEVICES WERE NOT RETURNED FOR EVALUATION. THE USER FACILITY DID PROVIDE A PICTURE OF THE INVOLVED DEVICES AND CLARIFIED THAT THERE WAS NO CUT, BREAKAGE OR DETACHMENT ALONG THE SHEATH. EXAMINATION OF THE PHOTO INDICATES THAT THE INVOLVED DEVICES HAD BEEN PUSHED IN THE FORWARD DIRECTION DURING INSERTION AND ENCOUNTERED SIGNIFICANT RESISTANCE. THE RESISTANCE DURING THE ATTEMPTED INSERTIONS WAS SUFFICIENT TO CAUSE DAMAGE TO THE INVOLVED DEVICES SUCH THAT BOTH INTRODUCER SHEATHS ARE NOW BENT NEAR THE DISTAL TIP WITH SIGNS OF PARTIAL BUCKLING FURTHER BACK ALONG THE SHAFT OF THE SHEATH. IN ADDITION, THE DAMAGE TO THE TIP OF THE SHEATH APPEARS TO HAVE CREATED A SLIGHT GAP BETWEEN THE TIP OF THE SHEATH AND THE DILATOR. IT IS CONJECTURED THAT THIS GAP MAY HAVE BEEN WHAT WAS ORIGINALLY REFERRED TO AS "SEPARATION OF THE SHEATH." THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION OR COMPLAINT RECORDS. RETENTION SAMPLES FROM 3 LOTS RECENTLY SHIPPED TO THE CUSTOMER WERE EVALUATED. INSPECTION OF THE RETAINED SAMPLES CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES. TESTING OF THE RETAINED SAMPLES CONFIRMED THAT PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A PRE-EXISTING DEVICE DEFECT. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THE PHOTOGRAPHIC APPEARANCE OF THE INVOLVED SAMPLES IS MOST CONSISTENT WITH DAMAGE TO INTRODUCER SHEATHS AS A RESULT OF CONTINUING TO ATTEMPT INSERTION AFTER ENCOUNTERING SIGNIFICANT RESISTANCE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE, WHICH STATES: "ADVANCE OR WITHDRAW THE SHEATH SLOWLY. IF RESISTANCE IS MET, DO NOT ADVANCE OR WITHDRAW THE SHEATH UNTIL THE CAUSE OF RESISTANCE HAS BEEN DETERMINED." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    PER THE USER FACILITY MEDWATCH REPORT # (B)(4), WHICH WAS RECEIVED FROM FDA ON (B)(6) 2013, THE EVENT IS DESCRIBED AS FOLLOWS: "WHILE ATTEMPTING TO GAIN ACCESS TO FEMORAL ARTERY BOTH 4 AND 5 FRENCH SHEATHS SEPARATED PRECLUDING ACCESS TO THE ARTERY. AFTER SEVERAL ATTEMPTS TO GAIN ACCESS AND THE BEGINNING ACCUMULATION OF A HEMATOMA TO THE OPERATIVE SITE, THE PHYSICIAN TERMINATED THE PROCEDURE. THE PROCEDURE WAS RESCHEDULED TO BE DONE THE FOLLOWING WEEK. HEMATOMA WAS MANAGED BY MANUAL PRESSURE. PATIENT WAS DISCHARGED WITHOUT FURTHER INCIDENT." PLEASE NOTE THAT FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT THE DEVICES ACTUALLY USED DURING THE EVENT WERE 4 AND 6 FRENCH SHEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147004 RADIFOCUS INTRODUCER II KIT GUIDING SHEATH DYB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR