BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE DESTINATION CAROTID GUIDING SHEATH

    MDR report key: 1736164 · Received June 21, 2010

    Report

    Report Number
    1118880-2010-00008
    Event Type
    Injury
    Date Received
    June 21, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 20, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K052185
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY, SUTURES WERE REQUIRED TO CLOSE THE ENTRY SITE FOLLOWING SHEATH REMOVAL. RESULTS AND CONCLUSIONS IS BASED UPON EVAL OF RETURNED SAMPLE & USER FACILITY INFO; BASED UPON TESTING OF RESERVE SAMPLES. THE FAILURE INVESTIGATION WAS BASED ON ASSESSMENT OF USER FACILITY INFO, RETURNED & RETAINED SAMPLES. THE PROCEDURAL NOTES FROM THE USER FACILITY DID NOT PROVIDE ANY ADDITIONAL DETAILED INFO ABOUT THE REPORTED SHEATH SEPARATION. VISUAL EXAM OF THE RETURN SAMPLE CONFIRMED THAT THE SHEATH TUBING HAD BEEN STRETCHED & THEN EVENTUALLY SEPARATED INTO TWO PIECES. CRIMPED AREAS WERE NOTED ADJACENT TO THE POINT OF SEPARATION, ALSO. HOWEVER, THE INNER COIL WIRE REMAINED INTACT CONNECTING THE SHEATH TUBING SECTIONS TOGETHER. INSPECTION AND TESTING OF REPRESENTATIVE RETAINED SAMPLES FOUND NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE AVAILABLE INFO IS CONSISTENT WITH THE SHEATH HAVING BEEN DAMAGED AS A RESULT OF CONTINUED ATTEMPTS TO WITHDRAW THE DEVICE AGAINST RESISTANCE. THE DEVICE LABELING STATES IN THE INSTRUCTIONS-FOR-USE: "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 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 WITHDRAWAL AFTER AN INTERVENTIONAL PROCEDURE IN THE SUBCLAVIAN THE GUIDING SHEATH BEGAN TO SEPARATE. F/U COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT: THE PARTIALLY SEPARATED SECTION REMAINED CONNECTED VIA THE INNER COIL WIRE; THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE DEVICE VIA THE ACCESS SITE; THE ACCESS SITE HAD TO BE SUTURED FOLLOWING THE SHEATH REMOVAL; THE PROCEDURE WAS COMPLETED; AND THE PT WAS SENT TO RECOVERY ROOM IN STABLE CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 6.0X20 FOXPLUS BALLOON| OMNILINK STENT| 6.0X18 OMNILINK BALLOON