BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 1631260 · Received March 11, 2010

    Report

    Report Number
    1118880-2010-00003
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 8, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NON-RESORBABLE MATERIAL UNRETRIEVED IN THE BODY. THE FAILURE INVESTIGATION WAS BASED ON ASSESSMENT OF USER FACILITY INFO, RETURNED AND RETAINED SAMPLES. VISUAL EXAMINATION OF THE RETURN SAMPLE CONFIRMED THAT THE SHEATH TUBING HAD BEEN STRETCHED AND THEN EVENTUALLY SEPARATED INTO 2 PIECES APPROX 3.5-CM FROM THE DISTAL END EXPOSING THE INNER COIL WIRE. INSPECTION AND TESTING OF REP 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. BASED ON USER FACILITY INFO, THE RESISTANCE DURING WITHDRAWAL WAS CAUSED BY THE SHEATH BECOMING CAUGHT ON ATHEROMATOUS PLAQUE IN THE FEMORAL ARTERY. THERE IS NO INDICATION THAT THE REPORTED SEPARATION WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE INSTRUCTIONS-FOR-USE BY STATING, "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 FOLLOW UP. (B) (4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DISTAL PORTION OF THE GUIDING SHEATH BECAME SEPARATED DURING REMOVAL AFTER A PROCEDURE. REPORTEDLY, THE DEVICE BECAME CAUGHT ON ATHEROMATOUS PLAQUE IN THE CONTRA-LATERAL FEMORAL ARTERY WHICH MADE REMOVAL OF THE SHEATH DIFFICULT. THE PHYSICIAN CONTINUED TO PULL ON THE SHEATH EVEN AFTER THE RESISTANCE WAS ENCOUNTERED UNTIL IT BROKE FREE. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL PORTION OF THE OUTER SHEATH HAD BECOME SEPARATED, EXPOSING THE COIL WIRE. THE DETACHED PORTION OF THE SHEATH WAS LEFT UNRETRIEVED. A STENT WAS PLACED TO COMPRESS AND HOLD THE MATERIAL AGAINST THE VESSEL WALL. THE PT CONDITION WAS REPORTED AS "NO HARM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other