BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM

    MDR report key: 8148969 · Received December 10, 2018

    Report

    Report Number
    2134265-2018-63348
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 19, 2018
    Report Date
    March 29, 2019
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION CONCLUSION CODE CORRECTED FROM 4315 TO 4311. DEVICE EVALUATED BY MFR:ANALYSIS OF RETURNED PRODUCT REVEALED THAT ONLY THE DISTAL FILTER WAS RECEIVED. A TEAR IS OBSERVED ON THE DISTAL FILTER. WITHOUT THE REST OF THE DEVICE, AN INVESTIGATION AS TO WHY THE HOLE FORMED COULD NOT BE PERFORMED. THE DHR REVIEW WAS PERFORMED BY CLARET MEDICAL ON LOT NUMBER 18D05H01 AND SHOWS THAT ALL ACCEPTANCE RECORDS DEMONSTRATE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORDTHE SENTINEL DEVICE IS INSPECTED DURING DEVICE PREPARATION. THE REPORTED FAILURE WAS NOTICED POST-PROCEDURE; THEREFORE, IT IS LIKELY THE HOLE FORMED DURING THE PROCEDURE, DURING REMOVAL OF THE SENTINEL DEICE, OR WHILE CHECKING THE FILTER CONTENTS, THEREFORE, MOST PROBABLE CAUSE IS: ADVERSE EVENT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR:ANALYSIS OF RETURNED PRODUCT REVEALED THAT ONLY THE DISTAL FILTER WAS RECEIVED. A TEAR IS OBSERVED ON THE DISTAL FILTER. WITHOUT THE REST OF THE DEVICE, AN INVESTIGATION AS TO WHY THE HOLE FORMED COULD NOT BE PERFORMED. THE DHR REVIEW WAS PERFORMED BY CLARET MEDICAL ON LOT NUMBER 18D05H01 AND SHOWS THAT ALL ACCEPTANCE RECORDS DEMONSTRATE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORDTHE SENTINEL DEVICE IS INSPECTED DURING DEVICE PREPARATION. THE REPORTED FAILURE WAS NOTICES POST-PROCEDURE; THEREFORE, IT IS LIKELY THE HOLE FORMED DURING THE PROCEDURE, DURING REMOVAL OF THE SENTINEL DEICE, OR WHILE CHECKING THE FILTER CONTENTS, HOWEVER, THIS CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL FILTER WAS PUNCTURED. A SENTINEL EMBOLIC PROTECTION DEVICE HAD BEEN SUCCESSFULLY USED IN THE PROCEDURE. AFTER RETRIEVAL OF THE SYSTEM, THE CONTENTS OF THE FILTER BASKETS WERE CHECKED AND A PUNCTURE IN THE DISTAL FILTER WAS DETECTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL FILTER WAS PUNCTURED. A SENTINEL EMBOLIC PROTECTION DEVICE HAD BEEN SUCCESSFULLY USED IN THE PROCEDURE. AFTER RETRIEVAL OF THE SYSTEM, THE CONTENTS OF THE FILTER BASKETS WERE CHECKED AND A PUNCTURE IN THE DISTAL FILTER WAS DETECTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL FILTER WAS PUNCTURED. A SENTINEL EMBOLIC PROTECTION DEVICE HAD BEEN SUCCESSFULLY USED IN THE PROCEDURE. AFTER RETRIEVAL OF THE SYSTEM, THE CONTENTS OF THE FILTER BASKETS WERE CHECKED AND A PUNCTURE IN THE DISTAL FILTER WAS DETECTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987835 SENTINEL CEREBRAL PROTECTION SYSTEM EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C 18D05H01

    Patients

    Seq Age Sex Outcome Treatment
    1