BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 6657614 · Received June 21, 2017

    Report

    Report Number
    2029214-2017-00823
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    May 22, 2017
    Report Date
    August 8, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS # (B)(4): EQUIPMENT USED: VIS (M-77148), 200CM RULER (M-75269) THE REBAR-18 MICRO CATHETER (MODEL: 105-5081-153 LOT: A411764) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN A PLASTIC BAG. THE TRAXCESS (MICROVENTION TERUMO) GUIDEWIRE WAS NOT RETURNED. THE TRAXCESS GUIDEWIRE HAS A PROXIMAL OD (OUTER DIAMETER) OF 0.014¿ AND DISTAL OD OF .012¿, AS PER AN ONLINE SOURCE. PER THE REBAR-18 MICRO CATHETER PRODUCT LABELING THE MAXIMUM GUIDEWIRE OD IS 0.018¿. THEREFORE, THE TRAXCESS GUIDEWIRE WAS FOUND TO BE COMPATIBLE FOR USE WITH THE REBAR-18 MICRO CATHETER. THE REBAR-18 MICRO CATHETER WAS DECONTAMINATED AS PER QAP15.5.1. WHEN COMPARED TO THE DRAWING DWGS105-5081-153 REV. AN: THE REBAR-18 MICRO CATHETER WAS FOUND TO BE SEPARATED INTO TWO SEGMENTS AND RETAINED BY THE INNER WIRE. THE TOTAL LENGTH OF THE PROXIMAL SEGMENT WAS MEASURED TO BE ~128.0CM. THE USEABLE LENGTH OF THE PROXIMAL SEGMENT WAS MEASURED TO BE ~121.3CM. THE USEABLE LENGTH OF THE DISTAL SEGMENT WAS MEASURED TO BE ~34.0CM. NO ISSUES WERE FOUND WITH THE REBAR-18 MICRO CATHETER HUB. THE REBAR-18 MICRO CATHETER BODY WAS FOUND TO BE STRETCHED AND ACCORDIONED AT THE DISTAL END OF PROXIMAL SEGMENT AND PROXIMAL END OF THE DISTAL SEGMENT. THE TUBING MATERIAL OF THE SEPARATED ENDS OF THE REBAR-18 MICRO CATHETER SEGMENTS EXHIBITED WITH STRETCHING, NECKING AND JAGGED EDGES. NO ISSUES WERE FOUND WITH THE REBAR-18 MICRO CATHETER DISTAL TIP. AN IN-HOUSE 0.018¿ GUIDEWIRE (PART: 90550-001 LOT: RC23927) WAS INSERTED INTO THE REBAR-18 MICRO CATHETER HUB; HOWEVER, THE GUIDEWIRE WAS UNABLE TO PASS THROUGH THE PROXIMAL SEPARATED END. THE IN-HOUSE 0.018¿ GUIDEWIRE WAS THEN INSERTED INTO THE REBAR-18 MICRO CATHETER DISTAL TIP; HOWEVER, THE GUIDEWIRE WAS UNABLE TO PASS THROUGH THE DISTAL SEPARATED END. NO OTHER ANOMALIES WERE OBSERVED. THERE WAS NO EVIDENCE FOUND OF MANUFACTURING DEFECTS. THE REBAR-18 MICRO CATHETER WILL BE RETAINED AS PER QAP15.5.1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE REBAR HAS BEEN RECEIVED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AFTER INTRODUCING THE GUIDEWIRE (TRAXCESS) INTO THE REBAR, RESISTANCE WAS FELT AT THE DISTAL END. AS A RESULT, THE SYSTEM WAS REMOVED AND IT WAS OBSERVED THAT THE REBAR WAS SEPARATED IN THE DISTAL SEGMENT. THE DEVICE WAS REPLACED WITH A REBAR 27, BUT WHEN FLUSHING THIS CATHETER DURING PREPARATION, IT WAS OBSERVED THAT THE MICROCATHETER WAS OBSTRUCTED BECAUSE SALINE WOULD NOT EXIT. THERE WAS NO DAMAGE OBSERVED TO THIS DEVICE IN THE PACKAGE. WHEN INSPECTING THE REBAR, THE PHYSICIAN NOTED THAT THE MIDDLE/DISTAL SECTION WAS OBSTRUCTED BY A CONTINUOUS FLATTENING. THE TIP WAS NOT GRABBED PRIOR TO FLUSHING, THE DEVICE WAS HANDLED CORRECTLY. THIS REBAR WAS REPLACED WITH ANOTHER TO CONTINUE THE PROCEDURE. NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT AS RECEIVING MECHANICAL THROMBECTOMY TREATMENT. VESSEL TORTUOSITY WAS MINIMAL. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS DIRECTED. ACCESSORY DEVICES: GUIDECATHETER (TRAXCESS - NON MEDTRONIC), TRAXCESS 14 GUIDEWIRE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AFTER INTRODUCING THE GUIDEWIRE (NON-MEDTRONIC DEVICE) INTO THE REBAR, RESISTANCE WAS FELT AT THE DISTAL END. AS A RESULT, THE SYSTEM WAS REMOVED AND IT WAS OBSERVED THAT THE REBAR WAS SEPARATED IN THE DISTAL SEGMENT. NO INJURY REPORTED. THE PATIENT AS RECEIVING MECHANICAL THROMBECTOMY TREATMENT. VESSEL TORTUOSITY WAS MINIMAL. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS DIRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438355 REBAR CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 105-5081-153 A411764

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR