BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER CTO RECANALIZATION CATHETER

    MDR report key: 6156949 · Received December 8, 2016

    Report

    Report Number
    2020394-2016-01152
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    10801741125598
    PMA / PMN Number
    K091119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL/MICROSCOPIC INSPECTION: THE DEVICE WAS RETURNED WITH THE PRODUCT PACKAGING AND LABEL. THE TIP WAS EXAMINED UNDER MAGNIFICATION (16X) AND THE OUTER CATHETER AND INNER GUIDEWIRE LUMEN WERE PULLED OUT FROM THE DISTAL METAL TIP. AS A RESULT, THE DISTAL METAL TIP WAS NOT ALIGNED WITH THE OUTER CATHETER. SLIGHT BUNCHING OF THE OUTER CATHETER WAS OBSERVED 1.5CM AND 16.4CM FROM THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED TO THE DEVICE. FUNCTIONAL/PERFORMANCE EVALUATION: DUE TO THE CONDITION OF THE RETURNED SAMPLE, A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS RETURNED. THE INVESTIGATION WAS CONFIRMED FOR MATERIAL SEPARATION BASED UPON THE CONDITION IN WHICH THE SAMPLE WAS RETURNED. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT WAS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT CROSSER CTO RECANALIZATION CATHETER INSTRUCTIONS FOR USE (IFU) STATES: WARNINGS AND PRECAUTIONS: WHEN USING THE CROSSER IN TORTUOUS ANATOMY, THE USE OF A SUPPORT CATHETER IS RECOMMENDED TO PREVENT KINKING OR PROLAPSE OF THE CROSSER CATHETER TIP. KINKING OR PROLAPSE OF THE TIP COULD CAUSE CATHETER BREAKAGE AND/OR MALFUNCTION. ADVERSE EVENTS: AS WITH MOST PERCUTANEOUS INTERVENTIONS, POTENTIAL ADVERSE EFFECTS INCLUDE: BLEEDING WHICH MAY REQUIRE TRANSFUSION OR SURGICAL INTERVENTION, HEMATOMA, PERFORATION, DISSECTION, GUIDEWIRE ENTRAPMENT AND/OR FRACTURE, HYPERTENSION/HYPOTENSION, INFECTION OR FEVER, ALLERGIC REACTION, PSEUDOANEURYSM OR FISTULA ANEURYSM, ACUTE RECLOSURE, THROMBOSIS, ISCHEMIC EVENTS, DISTAL EMBOLIZATION, EXCESSIVE CONTRAST LOAD RESULTING IN RENAL INSUFFICIENCY OR FAILURE, EXCESSIVE EXPOSURE TO RADIATION, STROKE/CVA, RESTENOSIS, REPEAT CATHETERIZATION / ANGIOPLASTY, PERIPHERAL ARTERY BYPASS, AMPUTATION, DEATH OR OTHER BLEEDING COMPLICATIONS AT ACCESS SITE. INTERVENTIONAL USE: SLOWLY ADVANCE THE CATHETER TIP THROUGH THE LESION. APPLY STEADY, CONSTANT PRESSURE SO THE TIP OF THE CATHETER IS ENGAGED TO THE LESION. UPON SUCCESSFUL RECANALIZATION OF THE LESION, ADVANCE THE GUIDEWIRE DISTAL TO THE LESION AND THEN WITHDRAW THE CROSSER 14P, 14S, OR 18 CATHETER. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER APPROXIMATELY TWO MINUTES OF ACTIVATION, A CT SCAN DEMONSTRATED THAT THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY SEPARATED FROM THE OUTER CATHETER BUT REMAINED ATTACHED TO THE INNER CORE WIRE. THE RECANALIZATION CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE HEALTH CARE PROVIDER USED A GUIDEWIRE AND BALLOON CATHETER TO SUCCESSFULLY CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER APPROXIMATELY TWO MINUTES OF ACTIVATION, A CT SCAN DEMONSTRATED THAT THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY SEPARATED FROM THE OUTER CATHETER BUT REMAINED ATTACHED TO THE INNER CORE WIRE. THE RECANALIZATION CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE HEALTH CARE PROVIDER USED A GUIDEWIRE AND BALLOON CATHETER TO SUCCESSFULLY CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805234 CROSSER CTO RECANALIZATION CATHETER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFAR2512 10801741125598

    Patients

    Seq Age Sex Outcome Treatment
    1