BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2073182 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03029
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    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: ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE BALLOON BEING INFLATED. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. POTENTIAL FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY INFLATING AND/OR WATERMELON SEEDING MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, DEVICE SIZE SELECTION, PLACEMENT OF THE BALLOON WITHIN THE LESION, OR PHYSICIAN TECHNIQUE. TO HELP ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, VARIOUS QUALITY CHECKS ARE IN PLACE TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION. A NEW INDEFLATOR WAS FILLED WITH CONTRAST MEDIUM, DILUTED 1:1 WITH COLORED WATER, AND WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP). THE BALLOON INFLATED TO RBP WITH NO ANOMALIES NOTED. THE INFLATION TIMES WERE MEASURED AND MET MANUFACTURING CRITERIA. IT WAS REPORTED THAT THE BALLOON DID NOT FULLY INFLATE WITH CONTRAST. THE TREK INSTRUCTIONS FOR USE (IFU) STATES: ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY OTHERWISE, COMPLICATIONS MAY OCCUR. IT IS POSSIBLE NOT ALL THE AIR WAS REMOVED FROM THE CATHETER, CONTRIBUTING IN THE REPORTED DIFFICULTIES; HOWEVER, THIS COULD NOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THE BALLOON WAS NOT SOAKED PRIOR TO USE. THE IFU STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING; HOWEVER, IT IS UNLIKELY THAT THE FAILURE TO SOAK THE BALLOON PRIOR TO USE CONTRIBUTED TO THE INFLATION DIFFICULTIES. THE NOTED BENDS IN THE HYPOTUBE LIKELY OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS AS THEY WERE NOT REPORTED IN THE CASE INFORMATION AND DO NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED INFLATION DIFFICULTIES. 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 INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED INFLATION ISSUES COULD NOT BE VERIFIED AND THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINI TREK BALLOON WAS PREPPED OUTSIDE OF THE BODY ON A PROWATER GUIDE WIRE. PRIOR TO USE, NEGATIVE PRESSURE WAS APPLIED TO THE MINI TREK TWICE. THE MINI TREK WAS NOT PRE-SOAKED. THE MINI TREK WAS INSERTED INTO THE CIRCUMFLEX ARTERY, WHICH HAD NO TORTUOSITY OR CALCIFICATION AND WAS 85% STENOSED. UPON INFLATION AT 4 ATMOSPHERES (ATM), ONLY HALF OF THE BALLOON WAS FULL OF CONTRAST AND AT 6 ATM IT WAS ONLY THREE QUARTERS FULL. NO RESISTANCE WAS EVER NOTED. A XIENCE V 2.5 X 18 WAS DEPLOYED AND THERE WAS NO PATIENT INJURY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 1012962

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR GUIDE WIRE: PROWATER