BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2100970 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03650
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: THE BALLOON CATHETER WAS RETURNED WITH CONTRAST VISIBLE IN THE INFLATION LUMEN AND ON THE SHAFT, WHICH IS CONSISTENT WITH HANDLING AND SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE. THE BALLOON WAS LOOSELY-FOLDED, WHICH IS ALSO CONSISTENT WITH THE DEVICE BEING PRESSURIZED, AS REPORTED. A NEW INDEFLATOR WAS USED TO INFLATE THE BALLOON TO ITS RATED BURST PRESSURE AND THE BALLOON INFLATED WITHOUT ANY ANOMALIES NOTED. ADDITIONALLY, FUNCTIONAL TESTING WAS PERFORMED TO MEASURE THE OUTER DIAMETER OF THE BALLOON AND THE INFLATION TIMES, WHICH MET MANUFACTURING SPECIFICATION. THERE WAS NO DAMAGE NOTED TO THE CATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. DIFFICULTY DURING INFLATION/BALLOON SLIPPING (WATERMELON SEEDING) WITHIN THE LESION MAY BE DUE TO FACTORS INCLUDING, BUT ARE NOT LIMITED TO, MANUFACTURING, MATERIAL PROPERTIES, BALLOON SIZE, PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, PLACEMENT OF THE BALLOON WITHIN LESION, OR INFLATION TECHNIQUE. BASED ON THE INFORMATION PROVIDED, THE LESION WAS HEAVILY TORTUOUS, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED. IF THE BALLOON WAS EXPANDED IN A NARROW PORTION OF THE LESION DURING INFLATION ATTEMPT, THIS CAN CAUSE THE BALLOON TO SLIP/WATERMELON SEED, ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED IN THIS CASE. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL BALLOONS ARE VISUALLY INSPECTED FOR PROPER FOLD CONFIGURATION AND A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION/DEFLATION. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. DISSECTIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A QUALITY DEFICIENCY ASSOCIATED WITH THE PRODUCT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND THE ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTY DURING INFLATION/BALLOON SLIPPING (WATERMELON SEEDING) COULD NOT BE DETERMINED; HOWEVER, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON CATHETER WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE AND WAS PRE-SOAKED. IT WAS THEN USED IN ORDER TO PERFORM PREDILATATION OF THE MID CIRCUMFLEX ARTERY THAT WAS VERY TORTUOUS AND ON A BEND. HOWEVER, UPON INFLATION AT 4 ATMOSPHERES (ATM) FOR 5 SECONDS, THE TREK BALLOON SLIPPED/WATERMELON SEEDED PROXIMALLY. THEN A VOYAGER 3.5 X 15 WAS ALSO USED FOR PREDILATATION WITH 2 INFLATIONS (ATM NOT NOTED). THEN, A XIENCE V 3.5 X 23 WAS IMPLANTED AT THE LESION SITE. ANGIOGRAPHY WAS PERFORMED AND THEN THE GUIDE WIRE (TYPE UNKNOWN) WAS REMOVED. AT THIS POINT, A DISSECTION WAS OBSERVED. THE VESSEL WAS REWIRED AND A XIENCE V 3.5 X 23 WAS IMPLANTED PROXIMALLY TO TREAT THE DISSECTION. IT IS THE PHYSICIAN'S BELIEF THAT THE TREK BALLOON CATHETER CAUSED THE PROXIMAL DISSECTION WHEN IT SLIPPED/WATERMELON SEEDED AT THE BEGINNING OF THE PROCEDURE. THE PHYSICIAN REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT IS DOING WELL AND WAS DISCHARGED TO RECOVERY. THERE WAS NO PATIENT SEQUELA. 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 1011762

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention