BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBE RX VASCULAR IMAGING BALLOON CATHETER

    MDR report key: 2191287 · Received July 19, 2011

    Report

    Report Number
    2939520-2011-00049
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MFR, SO A DEVICE EVAL HAS NOT BEEN PERFORMED YET. THE COMPLAINT DATABASE WAS REVIEWED AND TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THIS CASE WAS REVIEWED BY THE MFR'S CLINICAL AFFAIRS AND PRELIMINARY CLINICAL ASSESSMENT STATES THAT THE PT THUS FAR HAS NOT EXPERIENCED ANY ADVERSE CLINICAL EVENTS. NO CHEST PAIN OR ELECTROCARDIOGRAM (ECG) CHANGES WERE REPORTED. IT COULD BE SPECULATED THAT THE CATHETER COULD HAVE TORN WHEN UP AGAINST THE STENT STRUTS OR CALCIUM CAUSING THE TEAR IN THE VIBE BALLOON SEGMENT OF THE CATHETER. THE PHYSICIAN REPORTED ON ANGIOGRAM THE SMALL VESSEL DISSECTION THAT COULD HAVE HAPPENED FROM THE GUIDE WIRES OR OTHER INTERVENTIONAL DEVICES USED DURING THE PROCEDURE. NO ADDITIONAL MEASURES OR PHARMACEUTICALS WERE GIVEN TO THE PT AS THE PT APPEARED TO BE HEMODYNAMICALLY STABLE DURING THE PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE COMPLAINT DESCRIPTION FOR THIS INCIDENT WAS BASED ON THE SOURCE DOCUMENT AND THE EXPLANATION GIVEN BY THE MFR'S SALES REP AND PRODUCT MGR TO THE REGULATORY/QA COORDINATOR. THE AIM OF THE PROCEDURE WAS THE TREATMENT OF THE STENT RESTENOSIS: THE RIGHT CORONARY ARTERY (RCA) WAS TOTALLY OCCLUDED; PROXIMAL SEGMENT OF THE STENT. THE PHYSICIAN ADVANCED THE MFR'S BALLOON CATHETER (SIZE - 2.0 X 15MM) UNTIL THE PROXIMAL PART OF THE AREA OF INTEREST, HE COULD REACH THE AREA AND THEN HE INFLATED THE BALLOON WITH 4 ATM, THEN ADVANCED THE CATHETER THROUGH THE STENT AND INFLATED WITH 6 ATM AT THE DISTAL PART OF RESTENOSIS. THE PHYSICIAN CROSSED THE RESTENOSIS AND MADE A PULLBACK, IVUS WAS WORKING PROPERLY, HOWEVER, AFTERWARDS, IT WAS NOTICED THAT THEY DID NOT RECORD THE IVUS PULLBACK. NO IVUS IMAGES WERE OBTAINED. HE TRIED AGAIN TO PASS THE CATHETER AND THE CATHETER WAS NOT SUCCESSFULLY ADVANCED THE SECOND TIME THROUGH THE RESTENOSIS, THE BALLOON APPEARED TO BE KINKING WHEN HE TRIED TO ADVANCE THE CATHETER. THE PHYSICIAN REMOVED THE CATHETER OUT OF THE VESSEL AND INTO THE GUIDING CATHETER AND THEN THROUGH THE FEMORAL SHEATH WITHOUT DIFFICULTY. THE PHYSICIAN THEN INSPECTED THE CATHETER AND OBSERVED THE BALLOON OF THE CATHETER TO BE RIPPED AND APPEARED TO BE KINKED. THE MFR'S SALES REP AND PRODUCT MGR, WHO WERE PRESENT DURING THE PROCEDURE, OBSERVED AN "ACCORDION" FOLDING OF THE BALLOON AT ITS PROXIMAL END. THIS WAS THE REASON, IN THEIR OPINION, WHY IT WASN'T POSSIBLE TO ADVANCE THE CATHETER A SECOND TIME. ONCE THE PHYSICIAN REMOVED THE BALLOON CATHETER FROM THE PT, HE TRIED TO COMPLETE THE PROCEDURE WITH A NUMBER OF OTHER DEVICES (DIFFERENT MANUFACTURER). HOWEVER, AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DECIDED TO STOP THE PROCEDURE, AS A SMALL VESSEL DISSECTION WAS OBSERVED ON THE ANGIOGRAM. THE PHYSICIAN DECIDED TO CONTINUE THE PT'S TREATMENT IN A COUPLE OF WEEKS, ONCE THE DISSECTION IS HEALED. IT WAS FURTHER CONFIRMED BY THE PHYSICIAN THAT THE BALLOON CATHETER DID NOT CONTRIBUTE TO THE INJURY. THERE WERE NO VISIBLE SHARP EDGES DETECTED AROUND THE KINKED CATHETER. VISUAL AND MANUAL INSPECTION OF THE DEVICE BY THE PHYSICIAN AND THE 2 REPRESENTATIVES FROM THE MFR DID NOT RAISE SUSPICION AT ANY TIME. THE PT IS REPORTED TO BE DOING FINE. THERE WERE NO SIGNS OF ISCHEMIA OR MYOCARDIAL ISCHEMIA. THE HOSPITAL COURSE WAS UNEVENTFUL. THE PHYSICIAN REFRAINED FROM STENTING BECAUSE OF POOR VESSEL QUALITY OF THE DISTAL BED. THE PHYSICIAN INDICATED THAT WITH THIS DECISION HE PREVENTED A POSSIBLE COMPLICATION AND PROVED TO BE THE RIGHT DECISION. THE PT WAS RELEASED FROM THE HOSPITAL ACCORDING TO THE ORIGINAL TREATMENT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIBE RX VASCULAR IMAGING BALLOON CATHETER IVUS IMAGING BALLOON CATHETER OBJ VOLCANO CORPORATION 11-200-15 093 01013

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR