BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 3190008 · Received June 26, 2013

    Report

    Report Number
    1118880-2013-00026
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; BASED UPON EVALUATION OF RESERVE SAMPLES. CONCLUSIONS - BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; IS BASED UPON EVALUATION OF RESERVE SAMPLES. THE INVOLVED DEVICE WAS RETURNED AND EVALUATED. EXAMINATION CONFIRMED: (1) THE SHEATH TIP HAD BEEN DAMAGED AND TORN, BUT REMAINED ATTACHED TO THE DEVICE; AND EXAMINATION OF UNDAMAGED SECTIONS OF THE SHEATH HAD NO INDICATIONS OF MALFUNCTION OR PRE-EXISTING DEFECT. EVALUATION OF RESERVE SAMPLES FROM THE REPORTED LOT CONFIRMED NO EVIDENCE OF ABNORMALITIES OR DEFECTS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION AND APPEARANCE OF THE RETURNED SAMPLE ARE CONSISTENT WITH THE SHEATH HAVING BEEN DAMAGED AS A RESULT OF CONTINUED ATTEMPTS TO MANIPULATE THE DEVICE AGAINST 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

    THE USER FACILITY REPORTED THAT THE GUIDING SHEATH BECAME DAMAGED WHILE ATTEMPTING TO ADVANCE THE DEVICE DURING A LOWER EXTREMITY ANGIOPLASTY / STENT PLACEMENT PROCEDURE. COMMUNICATION WITH THE USER FACILITY INDICATED THE FOLLOWING: THE DEVICE WAS UNABLE TO BE ADVANCED DURING INSERTION INTO THE PATIENTS LEFT GROIN AND WAS REMOVED FROM THE PATIENT; UPON REMOVAL OF THE DEVICE IT WAS NOTED THAT THE DISTAL TIP OF THE SHEATH WAS ¿BUCKLED¿; AND (3) THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291627 PINNACLE DESTINATION RENAL GUIDING SHEATH GUIDING SHEATH DYB TERUMO MEDICAL CORPORATION NA PM24

    Patients

    Seq Age Sex Outcome Treatment
    1