BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2080706 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03254
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED TREK RX DILATATION CATHETER NOTED BLOOD AND CONTRAST VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENT ANATOMY. THE DISTAL SHAFT WAS WRINKLED PROXIMAL TO THE PROXIMAL SEAL. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE WRINKLED SHAFT MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON WHEN FLUID WAS OBSERVED LEAKING THROUGH THE GUIDE WIRE EXIT NOTCH. AFTER THE GUIDE WIRE EXIT NOTCH WAS PLUGGED WITH A PIN GAUGE AND HEMOSTATS WERE USED TO CLAMP THE TIP, THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE (RBP) WITH NO RUPTURE NOTED TO THE BALLOON. THERE WAS A HOLE IN THE INNER MEMBER DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A SCRATCH PROXIMAL TO THE HOLE IN THE INNER MEMBER. THE INNER MEMBER INSIDE THE BALLOON BECAME KINKED DURING TESTING. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE INNER MEMBER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE GUIDE WIRE. THERE WAS NO DAMAGE NOTED DURING THE INSPECTION PRIOR TO USE OR DURING PREPARATION WHICH SUGGESTS THE INNER MEMBER WAS NOT PREVIOUSLY DAMAGED. IT IS LIKELY THAT THE GUIDE WIRE INTERACTED WITH THE INNER MEMBER DURING BACK LOADING, RESULTING IN THE NOTED TEAR IN THE INNER MEMBER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES OR TEARS IN THE INNER MEMBER FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NOTED TEAR IN THE INNER MEMBER APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND LUMEN INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: RUNTHROUGH; GUIDE CATH: HEARTRAIL II JL4. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSIS IN THE DISTAL LEFT CIRCUMFLEX WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. THE TREK BALLOON CATHETER WAS USED FOR PRE-DILATATION OF THE LESION, BUT WHEN INFLATED FOR THE FIRST TIME, THE BALLOON RUPTURED AT 6-7 ATMOSPHERES. THE TREK WAS REPLACED WITH A NON-ABBOTT BALLOON DILATATION CATHETER, WHICH RUPTURED AT THE THIRD INFLATION. THE PROCEDURE WAS COMPLETED AFTER DEPLOYING A STENT. NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO REPORT OF SIGNIFICANT DELAY IN THE PROCEDURE. 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 0102662

    Patients

    Seq Age Sex Outcome Treatment
    1