BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2233217 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06131
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: EVALUATION OF THE RETURNED MINI TREK DILATATION CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, ON THE SHAFT AND THE LOOSELY FOLDED BALLOON AND CONTRAST IN THE BALLOON, CONSISTENT WITH PREPARATION AND USE OF THE CATHETER IN THE PATIENT ANATOMY. THE INNER MEMBER WAS NECKED PROXIMAL TO THE PROXIMAL SEAL. THE OUTER MEMBER WAS WRINKLED AT THE PROXIMAL SEAL. THERE WERE MULTIPLE SLIGHT BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS IN THE HYPOTUBE 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 DIFFICULTY WITH THE GUIDE WIRE. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT 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. A MANDREL WAS USED TO MEASURE THE INNER DIAMETER OF THE TIP AND GUIDE WIRE LUMEN AND THERE WAS STRONG RESISTANCE AT THE NECKED INNER MEMBER. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. A NEW .014 INCH GUIDE WIRE WAS BACKLOADED THROUGH THE BALLOON CATHETER AND THEN REMOVED WITH NO RESISTANCE NOTED. THE NEW GUIDE WIRE WAS BACKLOADED THROUGH THE BALLOON CATHETER; THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE (RBP) AND THE CATHETER WAS CHECKED FOR GUIDE WIRE REVERSIBILITY. THE GUIDE WIRE WAS FROZEN IN THE GUIDE WIRE LUMEN WHILE THE BALLOON WAS PRESSURIZED. THE BALLOON WAS ABLE TO BE REMOVED FROM THE GUIDE WIRE WITHOUT RESISTANCE WHEN THE INDEFLATOR WAS IN THE NEUTRAL POSITION. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS, AND AS THE GUIDE WIRE LUMEN WAS NOT NOTED TO BE COLLAPSED AFTER PRESSURIZATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, AS THE NOTED STRETCHED INNER MEMBER AND WRINKLED SHAFT DO NOT APPEAR TO HAVE CONTRIBUTED TO THE DIFFICULTY WITH THE GUIDE WIRE, THE DAMAGE LIKELY OCCURRED DURING THE ATTEMPTS TO REMOVE THE CATHETER FROM THE GUIDE WIRE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR), INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A REVIEW OF THE COMPLAINT-HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO REMOVE THE GUIDE WIRE OR SHAFT DAMAGE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, CHRONIC TOTAL OCCLUDED (CTO) RIGHT CORONARY ARTERY, THE MINI TREK WAS INFLATED ONCE INSIDE THE CTO AT 12 ATMOSPHERE FOR 30 SECONDS. THE MINI TREK WAS BEING RETRACTED FROM THE ANATOMY WHEN THE NON-ABBOTT GUIDE WIRE STUCK AND WAS INADVERTENTLY REMOVED WITH THE CATHETER AS A SYSTEM. ONCE OUTSIDE THE ANATOMY THE TWO DEVICES WERE SEPARATED. THERE WAS NO NOTED RESISTANCE DURING ADVANCING OF THE MINI TREK IN THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1031261

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RUNTHROUGH EXTRA FLOPPY