BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULLFROG MICRO-INFUSION CATHETER

    MDR report key: 4209371 · Received September 19, 2014

    Report

    Report Number
    3004142795-2014-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MERCATOR MEDSYSTEMS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INTERVENTION WAS REQUIRED WITH THE PT AS A RESULT OF THIS PRODUCT PROBLEM, AND ADD'L F/U WITH THE SURGEON HAS CONFIRMED NO PT IMPACT AS A RESULT OF THIS PRODUCT PROBLEM.

    Description of Event or Problem · 1

    THREE BULLFROG DEVICES (MODEL BF101L, LOT #00403) WERE USED IN THIS CASE. THIS MDR IS SUBMITTED REGARDING THE 2ND DEVICE USED IN THE CASE. THE PT HAD A 7MM REFERENCE DIAMETER SFA VESSEL WITH A 4 CM LONG OCCLUSIVE LESION (> 50% NARROWING). THIS LESION APPEARED TO BE MODERATELY CALCIFIED UNDER FLUOROSCOPY. FOLLOWING FEMORAL ACCESS THE LESION WAS CROSSED WITH A STANDARD GUIDEWIRE AND BALLOON ANGIOPLASTY (PTA) WAS PERFORMED SUCCESSFULLY. FOLLOWING THE BALLOON ANGIOPLASTY, THE FIRST BULLFROG DEVICE WAS PREPPED PER THE IFU INSTRUCTIONS, INSERTED INTO THE PT THROUGH A 7 FR COOK RAABE INTRODUCER SHEATH, AND THE 1ST BULLFROG CATHETER WAS INFLATED. AFTER A SERIES OF INFUSION ATTEMPTS, THE BALLOON RUPTURED. THE RUPTURE WAS THOUGHT TO BE A RESULT OF THE BALLOON'S INTERFACE WITH CALCIFICATION IN THE VESSEL. THE BULLFROG CATHETER WAS REMOVED SAFELY AND WITHOUT FURTHER INCIDENT, FROM THE PT. IT WAS DISCARDED. IT WAS NOTED THAT DELIVERY OF BOTH THE ANGIOPLASTY BALLOON AND THE BULLFROG DEVICE WERE DIFFICULT DUE TO THE PREVIOUS PLACEMENT OF STENTS IN THE COMMON FEMORAL AND PROFUNDA ARTERIES IN A PREVIOUS INTERVENTION. A 2ND BULLFROG DEVICE WAS PREPPED, AND THEN INSERTED THROUGH THE SHEATH AND DIRECTED TO THE INTENDED AREA OF DRUG DELIVERY. THE DEVICE WAS INFLATED AND COMPARABLE TO THE 1ST BULLFROG DEVICE, MULTIPLE ATTEMPTS AT INFUSION FAILED. AS WITH THE 1ST BULLFROG DEVICE, THERE WAS NO EVIDENCE OF PRESSURE RELIEF FROM THE RELIEF VALVE, AND SO PRESSURE WAS RAISED SLOWLY FROM 2 ATM TO 2.5 ATM TO HELP ENSURE BETTER VESSEL APPOSITION AND THUS IMPROVE THE OPPORTUNITY TO ENSURE NEEDLE DEPLOYMENT THROUGH THE MEDIA. THE BALLOON PORTION OF THE BULLFROG APPEARED TO BE APPOSED TO THE VESSEL AND DID NOT LOOK OUT OF CHARACTER. THE 2ND BULLFROG BALLOON WAS THEN SEEN UNDER FLUOROSCOPY TO RUPTURE, SIMILAR TO THE 1ST BULLFROG. THE 2ND BULLFROG WAS REMOVED FROM THE PT. BECAUSE BOTH BULLFROG DEVICES HAD RUPTURED AND NEITHER SHOWED EVIDENCE OF PRESSURE RE-LIEF THROUGH THE RELIEF VALVE, THIS 2ND BULLFROG WAS SAVED ON THE BACK TABLE TO LATER BE PACKAGED AND SHIPPED BACK TO (B)(4) FOR INVESTIGATION. IN THE 3RD ATTEMPT TO DELIVER DRUG LOCALLY WITH THE BULLFROG DEVICE, A 3RD DEVICE WAS PREPPED AND INSERTED INTO THE PT, AND INFLATED. THE BALLOON WAS INFLATED TO 2 ATM FILLING THE LUMEN OF THE VESSEL (FULL APPOSITION TO THE VESSEL WALL). IN THIS 3RD ATTEMPT, DRUG WAS SUCCESSFULLY INFUSED THROUGH THE BULLFROG CATHETER TO THE INTENDED SITES. THE DEVICE WAS THEN REMOVED WITHOUT ISSUE. THIS 3RD DEVICE WAS DISCARDED. A FINAL FULL RUNOFF ANGIOGRAM OF THE VESSEL FROM ILIAC BIFURCATION TO THE PEDAL ARTERY WAS COMPLETED AT THE END OF THE CASE. THE PROCEDURAL RESULT WAS CONFIRMED AS AN ACCEPTABLE REVASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585304 BULLFROG MICRO-INFUSION CATHETER CATHETER, CONTINUOUS, FLUSH KRA MERCATOR MEDSYSTEMS, INC. MDL09-4080-145 00403

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 7 FR COOK RAABE INTRODUCER SHEATH