BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 8130777 · Received December 4, 2018

    Report

    Report Number
    2029214-2018-01024
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    October 15, 2018
    Report Date
    January 14, 2019
    Manufacturer
    MEDTRONIC NEUROVASCULAR
    Product Code
    KRA
    UDI-DI
    00847536026834
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REBAR-18 MICRO CATHETER (MODEL: 105-5081-153 LOT: A648064) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN A SEALED TYVEK BIO-POUCH; WITHIN A PRIMARY SEALED PLASTIC BIO-POUCH AND WITHIN A SECONDARY RE-SEALABLE PLASTIC BIO-POUCH. THE SOLITAIRE PLATINUM REVASCULARIZATION DEVICE (PLI-20) WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE SITE. THE REBAR-18 MICRO CATHETER HAS A LABELED ID (INNER DIAMETER) OF 0.021¿. PER THE SOLITAIRE PLATINUM IFU (INSTRUCTIONS FOR USE) THE MINIMUM MICRO CATHETER ID IS 0.027¿. THEREFORE, THE REBAR-18 MICRO CATHETER WAS FOUND TO BE NOT COMPATIBLE FOR USE WITH THE SOLITAIRE PLATINUM REVASCULARIZATION DEVICE. THE REBAR-18 MICRO CATHETER WAS RETURNED SEPARATED INTO TWO SEGMENTS. THE TOTAL LENGTH OF THE PROXIMAL SEGMENT WAS MEASURED TO BE ~34.6CM AND THE USEABLE LENGTH WAS MEASURED TO BE ~27.8CM. THE USEABLE LENGTH OF THE DISTAL SEGMENT WAS MEASURED TO BE ~127.0CM. THE COMBINED USEABLE LENGTHS OF BOTH CATHETER SEGMENTS IS ~154.8CM (SPECIFICATION: 153.0CM ± 2.5CM). IT APPEARS THERE ARE NO MISSING CATHETER SEGMENTS. THE TUBING MATERIAL OF THE CATHETER SEPARATED ENDS EXHIBITED WITH STRETCHING AND JAGGED EDGES. THE REBAR-18 CATHETER DISTAL SEGMENT WAS FOUND TO HAVE SEPARATED AT ~0.5CM FROM THE PROXIMAL END, RETAINED BY THE INNER WIRE. IN ADDITION, THE REBAR-18 CATHETER DISTAL CATHETER SEGMENT WAS FOUND TO BE KINKED AT ~14.0CM AND 12.0CM FROM THE DISTAL TIP. THE REBAR-18 DISTAL MARKER BAND WAS FOUND TO BE CRUSHED. DUE TO ITS DAMAGED CONDITION, THE REBAR-18 MICRO CATHETER COULD NOT BE USED FOR RESISTANCE TESTING. NO OTHER ANOMALIES WERE OBSERVED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING THE MECHANICAL THROMBECTOMY CASE, THE REBAR 18 WAS REPORTED TO HAVE SEPARATED IN THE MIDDLE / PROXIMAL SECTION, WITH RESISTANCE NOTED UPON RETREIVAL. THE WHOLE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENT WAS TREATED WITH A SOLITAIRE PLATINUM 6-40. UPON RETRIEVAL OF THE SOLITAIRE AND REBAR RESISTANCE WAS FELT AND THE REBAR SEPARATED. THE SEPARATED PIECE WAS REPORTED TO HAVE BEEN REMOVED FROM THE PATIENT. THE SOLITAIRE 6-40 WAS NOT USED PER THE INSTRUCTIONS FOR USE, AS IT IS NOT COMPATIBLE FOR USE WITH A REBAR 18. THE PATIENT WAS ASYMPTOMATIC AS A RESULT OF THIS EVENT. THE ANATOMY WAS MODERATE IN TORTUOSITY. THE WHOLE REBAR CATHETER WILL BE RETURNED FOR ANALYSIS. THE TREATING LOCATION WAS THE LEFT M1. THERE WAS NO NOTICEABLE DAMAGE TO ANY OF THE DEVICES. THE SOLITAIRE AND THE CELLO WERE BOTH DISCARDED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970740 REBAR CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC NEUROVASCULAR 105-5081-153 A648064 00847536026834

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR