BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 6140214 · Received December 1, 2016

    Report

    Report Number
    2939520-2016-00081
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K143701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPT TO OBTAIN A PATIENT IDENTIFIER WAS UNSUCCESSFUL. THE FACILITY DECLINED TO SHARE IDENTIFYING INFORMATION. ATTEMPTS TO OBTAIN THE PATIENT INFORMATION WERE MADE VIA EMAIL. ALL REASONABLY KNOWN PATIENT INFORMATION IS INCLUDED IN THIS REPORT. RELEVANT TEST/LAB DATA: NO TESTS/LABORATORY DATA WAS AVAILABLE. RELEVANT HISTORY: NO INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THE CONNECTION SIGNAL WAS LOST DURING THE PROCEDURE. THE PATIENT PARTICIPATED IN A PILOT STUDY IN (B)(6) ON IVUS IMAGING ON PULMONARY VEIN AFTER CRYO ABLATION TO TREAT ATRIAL FIBRILLATION. THIS IS NOT A STUDY SPONSORED BY THE MANUFACTURER. THE FACILITY HAD DONE FOUR (4) IVUS PULLBACKS. AFTER PERFORMING CRYO, WHEN THEY WENT TO CHECK THE RESULTS, A MESSAGE DISPLAYED, "ENTER CATHETER TO THE PIM." THE CATHETER WAS OUTSIDE OF THE BODY WHEN THE ERROR CODE APPEARED AND THE TOWER WAS IN FFR MODE. THE DEVICE WAS DISCONNECTED AND RECONNECTED A FEW TIMES WITHOUT SUCCESS. THE FACILITY INDICATED THE GUIDEWIRE AND CATHETER WERE REMOVED AS A SYSTEM. A SECOND CATHETER OF SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENTS EXPERIENCED. TREATMENT WAS COMPLETE BY THE PROCEDURE. PATIENT WAS DISCHARGED AS EXPECTED. CONDITION OF THE PATIENT AT THE 3-MONTH FOLLOW-UP WAS DESCRIBED AS "VERY GOOD." THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO DAMAGE WAS OBSERVED. ALL PORTIONS OF THE DEVICE APPEARED ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT. NO RESISTANCE WAS FELT AT ANY TIME. NO DAMAGE WAS OBSERVED UPON REMOVAL. THE RETURNED DEVICE WAS INSPECTED AND THERE WAS BLOOD PRESENT WITHIN THE PROXIMAL FILLET, THE INNER LUMEN WAS PUNCTURED 220 MM FROM THE DISTAL TIP, OUTER LUMEN WAS TORN ABOVE THE PUNCTURE AND THE BLACK AND BROWN MICROCABLES WERE PROTRUDING OUT OF THE DISTAL SHAFT FROM THE TEAR, THE YELLOW MICROCABLE WAS SEVERED AT THE TEAR AND REMAINED WITHIN THE DEVICE. THREE OPEN CONNECTIONS AND ONE INTERMITTENT OPEN CONNECTION WERE PRESENT DURING THE WIRE BOND TEST. THE DEVICE FAILED EVERY ASPECT OF THE APT TEST. THE DEVICE FAILED TO BE RECOGNIZED BY THE IMAGING SYSTEM. THE COMPLAINT REPORTED "NO CATHETER" MESSAGE WAS DUPLICATED BY THE INVESTIGATION. THE PROBABLE CAUSE OF THE REPORTED FAILURE WOULD BE DAMAGE IN USE THAT RESULTED IN TORN MICROCABLES WHICH LED TO THE LOSS OF CONNECTION. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION AS THE MEDICAL DIRECTOR INDICATED DISRUPTION OF THE CATHETER SHAFT WITH EXTERNALLY PROTRUDING MICROABLES CAN DAMAGE BLOOD VESSEL WALLS. THEREFORE, IF THIS TYPE OF FAILURE WERE TO RECUR, IT MAY CAUSE PATIENT INJURY (E.G., DISSECTION, PERFORATION, THROMBOEMBOLISM). THE INSTRUCTIONS FOR USE (IFU) CAUTION, "WHEN INSERTING THE GUIDE WIRE BOTH CATHETER AND WIRE MUST BE STRAIGHT WITH NO BENDS OR KINKS, OR DAMAGE TO INNER LUMEN MAY OCCUR. DO NOT ADVANCE THE GUIDE WIRE AGAINST SIGNIFICANT RESISTANCE. IF BINDING OCCURS BETWEEN THE CATHETER AND THE GUIDE WIRE WHILE INSIDE THE PATIENT, CAREFULLY REMOVE BOTH THE WIRE AND CATHETER AND DO NOT USE. IF BINDING OCCURS OUTSIDE OF THE PATIENT, REMOVE THE CATHETER AND DO NOT USE. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. IF RESISTANCE IS ENCOUNTERED DURING PULLBACK, REMOVE THE ENTIRE SYSTEM (GUIDE WIRE, IVUS CATHETER, SHEATH/GUIDE CATHETER) AT THE SAME TIME." POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: MYOCARDIAL INFARCTION; OCCLUSION; CORONARY VESSEL DISSECTION; PERFORATION, RUPTURE OR INJURY; RESTENOSIS; HEMORRHAGE OR HEMATOMA; UNSTABLE ANGINA; ARRHYTHMIAS; DRUG REACTIONS; ALLERGIC REACTION TO CONTRAST MEDIUM; HYPO/HYPERTENSION; INFECTION; VESSEL SPASM; ARTERIOVENOUS FISTULA; EMBOLISM; ENTRY PUNCTURE SITE BLEEDING; VASCULAR WALL INJURY; VESSEL THROMBOSIS; PSEUDOANEURYSM (AT SITE OF CATHETER INSERTION); RENAL FAILURE; CORONARY ANEURYSM; VESSEL TRAUMA REQUIRING SURGICAL REPAIR OR INTERVENTION, DEATH. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788144 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 85900P 0127 50070141

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR