BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 2020784 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00687
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION REVEALED THE MICROCATHETER WAS RETURNED WITHIN A NON BSC 0.038IN GUIDE CATHETER. THE MICRO CATHETER WAS BROKEN 43.6CM FROM THE PROXIMAL END AND THE BRAID WAS ELONGATED. THERE WAS A LARGE AMOUNT OF DRIED BLOOD PRESENT IN THE HUB. THE DISTAL TIP OF THE MICRO CATHETER WAS PROTRUDING FROM THE DISTAL TIP OF THE GUIDE CATHETER. THE MICRO CATHETER COULD NOT BE REMOVED FROM THE GUIDE CATHETER. A KINK WAS NOTED ON THE DISTAL TIP 14.5CM FROM THE DISTAL END. AN APPROPRIATE SIZED MANDREL WAS ADVANCED THROUGH THE MICRO CATHETER HUB AND RESISTANCE WAS EXPERIENCED DUE TO THE LARGE AMOUNT OF BLOOD WITHIN THE CATHETER SHAFT. THE MANDREL WAS ADVANCED THROUGH THE DISTAL TIP FOR 25CM, BUT AGAIN MET RESISTANCE DUE TO THE PRESENCE OF BLOOD WITHIN THE CATHETER SHAFT. A COATING CONFIRMATION TEST WAS PERFORMED AND REVEALED COATING WAS PRESENT; HOWEVER, COATING DAMAGE WAS EVIDENT. THERE WAS NO PEELING OR MISSING COATING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS CONTINUOUS FLUSHING WAS NOT MAINTAINED AS INSTRUCTED IN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-00900, 2134265-2011-00688, 2134265-2011-00901. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESIONS WERE LOCATED IN THE SEVERELY TORTUOUS EXTERNAL AND COMMON CAROTID ARTERIES ON THE PATIENT¿S RIGHT SIDE. INTERMITTENT FLUSHING WITH HEPARINIZED SALINE WAS UTILIZED. A 150/10 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED OVER A TRANSEND GUIDE WIRE. AT AN UNSPECIFIED TIME, THE RENEGADE BECAME STUCK ON THE TRANSEND WIRE AND BROKE UPON REMOVAL FROM A NON BSC 5FR GUIDE CATHETER. A SECOND 150/10 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED. RESISTANCE WAS NOTED WHILE ADVANCING INTO THE VESSEL AND THIS RENEGADE BECAME KINKED. AT AN UNSPECIFIED TIME, THIS CATHETER WAS STUCK ON THE TRANSEND WIRE AND WHILE REMOVING THE DEVICE FROM A NON BSC 5FR GUIDE CATHETER, THE RENEGADE BROKE. A THIRD 150/10 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED AND AT AN UNSPECIFIED TIME, IT BECAME STUCK ON THE TRANSEND GUIDE WIRE AND BROKE DURING REMOVAL FROM A NON BSC 5FR GUIDE CATHETER. EACH OF THE RENEGADE MICROCATHETERS WERE BROKEN IN THE "MID DISTAL THIRD". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-00900, 2134265-2011-00688, 2134265-2011-00901. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESIONS WERE LOCATED IN THE SEVERELY TORTUOUS EXTERNAL AND COMMON CAROTID ARTERIES ON THE PATIENT¿S RIGHT SIDE. INTERMITTENT FLUSHING WITH HEPARINIZED SALINE WAS UTILIZED. A 150/10 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED OVER A TRANSEND GUIDE WIRE. AT AN UNSPECIFIED TIME, THE RENEGADE BECAME STUCK ON THE TRANSEND WIRE AND BROKE UPON REMOVAL FROM A NON BSC 5FR GUIDE CATHETER. A SECOND 150/10 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED. RESISTANCE WAS NOTED WHILE ADVANCING INTO THE VESSEL AND THIS RENEGADE BECAME KINKED. AT AN UNSPECIFIED TIME, THIS CATHETER WAS STUCK ON THE TRANSEND WIRE AND WHILE REMOVING THE DEVICE FROM A NON BSC 5FR GUIDE CATHETER, THE RENEGADE BROKE. A THIRD 150/10 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED AND AT AN UNSPECIFIED TIME, IT BECAME STUCK ON THE TRANSEND GUIDE WIRE AND BROKE DURING REMOVAL FROM A NON BSC 5FR GUIDE CATHETER. EACH OF THE RENEGADE MICROCATHETERS WERE BROKEN IN THE "MID DISTAL THIRD". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182900 13109297

    Patients

    Seq Age Sex Outcome Treatment
    1 5FR GLIDECATH GUIDE CATHETER| TRANSEND GUIDE WIRE| (2) RENEGADE HI-FLO 150/10| 5FR VERT GUIDE CATHETER