BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2061175 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02697
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN AND BALLOON, CONSISTENT WITH PREPARATION AND USE OF THE CATHETER IN THE PATIENT ANATOMY. THE BALLOON WAS RETURNED FLAT. THE DISTAL SHAFT WAS KINKED 4.6 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE HYPOTUBE WAS BENT 16.5, 23, 28, AND 36 CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE: INTERACTION OF THE BALLOON WITH A STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE IMPLANTED STENT, DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER OR INTRODUCER SHEATH. THE GUIDING CATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE BALLOON CATHETER COULD NOT BE ADVANCED THROUGH A NEW GUIDING CATHETER AS RETURNED DUE TO THE FLAT BALLOON. AFTER PRESSURIZING AND DEFLATING THE BALLOON CATHETER, THE BALLOON DEFLATED IN A TRI-FOLD. THE BALLOON CATHETER WAS THEN ADVANCED THROUGH A NEW GUIDING CATHETER AND WITHDRAWN WITHOUT ANY RESISTANCE NOTED. IT WAS NOTED THAT THE BALLOON WAS RETURNED FLAT, WHICH CAN BE A RESULT OF MULTIPLE OR HIGH PRESSURE INFLATIONS. IT IS POSSIBLE THAT A FLAT BALLOON COULD HAVE INTERACTED WITH THE STENT AND CONTRIBUTED TO THE REPORTED DIFFICULTY, BUT A FLAT BALLOON IS NOT UNCOMMON (ESPECIALLY WHEN DEFLATED OUTSIDE OF THE BODY) AND IT IS UNKNOWN IF THE BALLOON DEFLATED IN THE SAME MANNER DURING USE. ADDITIONALLY, IT WAS REPORTED A 6FR GUIDING CATHETER WAS USED, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES. IT SHOULD BE NOTED THE TREK INSTRUCTIONS FOR USE (IFU) STATES: WITH 4.5 MM AND 5.0 MM BALLOON DILATATION CATHETERS, SOME INCREASED RESISTANCE MAY BE NOTED UPON INSERTION OR WITHDRAWAL INTO OR OUT OF THE GUIDING CATHETER. CHOOSING A LARGER GUIDING CATHETER SIZE MAY MINIMIZE THIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER POST DILATATION OF A XIENCE STENT IMPLANTED IN THE LEFT MAIN (LM) ARTERY, RESISTANCE WAS FELT TRYING TO WITHDRAW THE BALLOON INTO A NON-ABBOTT GUIDING CATHETER. AN ADDITIONAL INFLATION/DEFLATION OF THE BALLOON WAS DONE CLOSE TO THE RATED BURST PRESSURE; HOWEVER, THE BALLOON STILL FELT TIGHT DURING ATTEMPTS TO WITHDRAW IT INTO THE GUIDING CATHETER, SO ALL OF THE DEVICES WERE REMOVED AS ONE UNIT. AN ANGIOGRAM WAS PERFORMED AND THE XIENCE V IMPLANTED IN THE LM LOOKED GOOD. THE PHYSICIAN FELT THE BALLOON DIDN'T REWRAP PROPERLY AND THAT IS WHAT MAY HAVE CAUSED THE RESISTANCE. THERE WERE NO PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0072761

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: MEDTRONIC EBU 3.5 6F, STENT: XIENCE V