BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 7420088 · Received April 10, 2018

    Report

    Report Number
    3003775027-2018-00071
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 29, 2018
    Report Date
    March 29, 2018
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    UDI-DI
    04547327055857
    PMA / PMN Number
    K031277
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN BLOCK B4 "DATE OF THIS REPORT" WAS ERRONEOUSLY REPORTED AS THE DATE THE REPORT WAS SUBMITTED RATHER THAN THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY. CORRECTIVE ACTION HAS BEEN TAKEN TO CLARIFY WHICH DATE SHOULD BE PROVIDED IN THE REPORT. THIS SUPPLEMENTAL REPORT IS INTENDED ONLY TO CORRECT THE DATE PROVIDED IN BLOCK B4 TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCT: PINNACLE DESTINATION INTRODUCER SHEATH; PIONEER REENTRY DEVICE. FAILURE TO FOLLOW STEPS. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED. INSTRUCTIONS FOR USE STATES: DO NOT USE THIS GUIDE WIRE IN COMBINATION WITH CATHETERS (ATHERECTOMY CATHETER, METALLIC DILATOR ETC.) WHICH METALLIC PARTS MAY CONTACT SURFACE OF THIS GUIDE WIRE. OTHERWISE, THIS GUIDE WIRE MAY BE DAMAGED OR BREAK APART. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE DEVICE IS MANUFACTURED BY (B)(4). ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE EMBOSHIELD REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED AND TORTUOUS ILIAC ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE WAS PLACED FOR DISTAL PROTECTION. THE GRAND SLAM GUIDE WIRE WAS PLACED SUBINTIMALLY. DURING USE OF A NON-ABBOTT REENTRY DEVICE, THE REENTRY DEVICE NEEDLE PIERCED THE GUIDE WIRE AND SHEARED OFF A PORTION OF THE GUIDE WIRE. THE SEPARATED GUIDE WIRE PORTION REMAINS IN THE PATIENT ANATOMY. NO ATTEMPT WAS MADE TO REMOVE THE SEPARATED GUIDE WIRE SEGMENT. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE FILTER WAS PULLED INTO THE RETRIEVAL CATHETER WITHOUT DIFFICULTY; HOWEVER, DURING REMOVAL, THE RETRIEVAL CATHETER KINKED AND WAS DIFFICULT TO REMOVE FROM THE NON-ABBOTT INTRODUCER SHEATH. THE INTRODUCER SHEATH AND RETRIEVAL CATHETER WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT WITH REGARDS TO THE EMBOSHIELD NAV6. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254405 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI AG141302 151117A051 04547327055857

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other SEE H10 FOR CONCOMITANT MEDICAL DEVICES