BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 21831200 · Received April 11, 2025

    Report

    Report Number
    9612501-2025-01029
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 3, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #(B)(4):EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-81805), RULER (M-83360), CAMERA (PANASONIC LUMIX DMC-ZS5) DRAWING(S) REFERENCED: DWGS105-5081-153 REV. AY AS FOUND CONDITION: THE REBAR 18 CATHETER WAS RETURNED FOR ANALYSIS INSIDE A SEALED BIOHAZARD BAG AND A SHIPPING BOX. DAMAGED LOCATION DETAILS: THE REBAR 18 CATHETER TIP AND MARKER WERE EXAMINED, AND NO DAMAGES WERE NOTED. NO DAMAGES WERE NOTED ON THE CATHETER BODY. NO VOIDS OR FLASHES WERE FOUND ON THE CATHETER HUB, AND NO OTHER ANOMALIES WERE FOUND. TESTING/ANALYSIS: THE REBAR 18 CATHETER¿S TOTAL AND USABLE LENGTHS WERE MEASURED WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND FOUND PATENT. THE CATHETER WAS TESTED BY RUNNING AN IN-HOUSE 0.021-INCH MANDREL THROUGH THE HUB AND TIP WITHOUT ISSUES. CONCLUSION: BASED ON THE REPORTED INFORMATION AND DEVICE ANALYSIS, THE CUSTOMER¿S ¿CATHETER RESISTANCE¿ COMPLAINT COULD NOT BE CONFIRMED, AS NO ISSUES WERE ENCOUNTERED WHILE TESTING THE RETURNED REBAR 18 CATHETER, AND NO DAMAGES WERE NOTED. HOWEVER, THE ROOT CAUSE OF THE RESISTANCE COMPLAINT COULD NOT BE DETERMINED. POSSIBLE CAUSES INCLUDE MODERATE VESSEL TORTUOSITY, INCOMPATIBLE/DAMAGED DEVICES, A TOO-LOW FLUSH RATE, AND A LACK OF CONTINUOUS FLUSH WITH HEPARINIZED SALINE DURING DELIVERY. IN THIS EVENT, THE REPORTED NON-MDT (CATALYST 7) ACCESS CATHETER WAS COMPATIBLE WITH THE REBAR 18 CATHETER, RULING OUT INCOMPATIBILITY AS A POTENTIAL CAUSE. THEREFORE, MODERATE VESSEL TORTUOSITY, DAMAGED DEVICES, A TOO-LOW FLUSH RATE, OR A LACK OF CONTINUOUS FLUSH WITH HEPARINIZED SALINE DURING DELIVERY MAY HAVE CONTRIBUTED TO THE RESISTANCE FAILURE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A MICRO CATHETER 105-5081-153 REBAR IR, THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 8MM. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. ADDITIONAL INFORMATION RECEIVED REPORTED LESION CHARACTERISTICS: DISTAL M1 SEGMENT RIGHT. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL TO MODERATE, WITH LIGHT ELONGATION. THE PATIENT WAS RECOVERING PERFECTLY FROM THE PROCEDURE. THE PROCEDURE WAS A MECHANICAL THROMBECTOMY. THE REBAR BECAME STUCK IN THE KATALYST 7 AND WAS STRETCHED THEREFOR A LITTLE WHEN THE CUSTOMER TRIED TO PULL THE REBAR BACK. THEY HAD TO PULL BACK BOTH (REBAR & KATALYST) EN BLOC A LITTLE, BEFORE REBARCOULD BE REMOVED, KATALYST 7 REMAINED IN PLACE, A 21 NEUROSLIDER WAS USED TO FINISH THE PROCEDURE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079311 REBAR CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC DOMINICANA 105-5081-153 0227695068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown