BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2082450 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03339
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE 7 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. AGAINST RESISTANCE. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN AND ON THE SHAFT, CONSISTENT WITH PREPARATION AND THE CATHETER AT LEAST PARTIALLY ADVANCED OVER THE GUIDE WIRE. THE BALLOON WAS TIGHTLY FOLDED. THE DISTAL END OF THE TIP WAS FLARED. THE BALLOON CATHETER WAS RETURNED FROZEN ON A BALANCE MIDDLEWEIGHT UNIVERSAL (BMW) GUIDE WIRE. THERE WAS 43.3 CM OF THE DISTAL END OF THE GUIDE WIRE EXTENDING OUT FROM THE TIP OF THE BALLOON CATHETER. THERE WAS A BALL OF LIGHT BLUE FIBERS ON THE GUIDE WIRE CORE AT THE PROXIMAL END OF THE HYPOTUBE. THE BALL OF FIBERS ON THE GUIDE WIRE CORE WERE AT THE DISTAL END OF THE BALLOON CATHETER TIP. THERE WAS A KINK IN THE BAYONET PORTION OF THE HYPOTUBE 9.5 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A BEND IN THE HYPOTUBE 4.5 CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE TIP DAMAGE, KINK AND BEND MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST ON THE POLYMER AND ON THE COILS. THERE WERE TWO BENDS IN THE GUIDE WIRE TIP 3 MM AND 7 MM PROXIMAL TO THE TIP BALL. THERE WAS A KINK IN THE GUIDE WIRE CORE 1.3 CM DISTAL TO THE PROXIMAL END OF THE CORE. THE DISTAL END OF THE GUIDE WIRE COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED TO THE TIP. THE OUTER DIAMETER OF THE CORE OF THE GUIDE WIRE UP TO THE BALLOON CATHETER GUIDE WIRE EXIT NOTCH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE DIMENSIONAL TEST ON THE BALLOON CATHETER COULD NOT BE DONE DUE TO THE GUIDE WIRE BEING FROZEN IN THE GUIDE WIRE LUMEN. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE FROM THE BALLOON CATHETER, BUT THE GUIDE WIRE COULD NOT BE REMOVED. AFTER THE GUIDE WIRE AND BALLOON CATHETER WERE SOAKED IN THE WATER BATH FOR THREE DAYS, THE GUIDE WIRE COULD NOT BE REMOVED FROM THE BALLOON CATHETER. THE GUIDE WIRE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE STILL INTACT. IN THIS CASE, IT IS LIKELY THAT THE COAGULATION OF BLOOD AND CONTRAST ON THE GUIDE WIRE AND IN THE GUIDE WIRE LUMEN OF THE CATHETER CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT WAS REPORTED THAT FORCE WAS APPLIED AS RESISTANCE WAS ENCOUNTERED. IT SHOULD BE NOTED THE TREK INSTRUCTIONS FOR USE STATES: IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND/OR DAMAGE/SEPARATION OF THE CATHETER. THE REPORTED FORCE APPLIED TO THE CATHETER AS RESISTANCE WAS ENCOUNTERED DOES NOT APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. CHEMICAL ANALYSIS OF THE GUIDE WIRE AND BLUE FIBERS INDICATED THAT ALL LIGHT BLUE FIBERS REMOVED FROM THE GUIDE WIRE RESEMBLE A TYPE OF CELLULOSE FIBER WITH ORIGIN REMAINING AS UNKNOWN. THIS TYPE OF GUIDE WIRE DOES NOT HAVE ANY BLUE COLORED COATING WHICH WOULD INDICATE THAT THE REPORTED BLUE COATING THAT ROLLED INTO A BALL WAS NOT PART OF THE GUIDE WIRE OR BALLOON CATHETER AND THERE WAS NO REPORTED DAMAGE DURING INSPECTION PRIOR TO USE. IT IS LIKELY THAT THE GUIDE WIRE WAS INADVERTENTLY HANDLED OR WIPED DOWN PRIOR TO USE, LEAVING FIBERS FROM A CLOTH ON THE GUIDE WIRE WHICH FURTHER CONTRIBUTED TO THE DIFFICULTIES BETWEEN THE DEVICES. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULTY POSITIONING/REMOVING THE GUIDE WIRE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MID LEFT ANTERIOR DESCENDING ARTERY, DURING ADVANCEMENT OF THE TREK DILATATION CATHETER OVER A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE, RESISTANCE WAS FELT AND FORCE WAS APPLIED. IT WAS NOTED THAT THE BLUE HYDROPHILIC COATING ON THE GUIDE WIRE HAD ROLLED INTO A BALL. THE DEVICES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THE PHYSICIAN MADE THE DECISION TO DISCONTINUE THE PROCEDURE. THE PATIENT HAS BEEN REFERRED FOR SURGERY. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0092861

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II