BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2001932 · Received February 27, 2011

    Report

    Report Number
    2024168-2011-01230
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    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: EVALUATION OF THE RETURNED MINI-TREK NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST ON THE SHAFT AND IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, WHICH IS CONSISTENT WITH PREPARATION AND USE OF THE PRODUCT. THERE WERE SEVERAL KINKS IN THE HYPOTUBE CONFIRMING THE REPORTED KINKS. 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. REPORTEDLY, THE MINI-TREK WAS USED IN A 100% RESTENOSED STENT, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED WATERMELON SEEDING. A KINK CAN OCCUR DURING MANUFACTURING, REMOVAL FROM THE PACKAGING AT THE ACCOUNT, HANDLING OF THE PRODUCT DURING PREPARATION FOR USE OR DURING USE. IT IS LIKELY THE CATHETER BECAME KINKED DURING ADVANCEMENT IN THE LESION OR FROM MANIPULATION OF THE SHAFT OUTSIDE OF THE ANATOMY AS THERE WAS NO DAMAGE NOTED DURING THE INSPECTION PRIOR TO USE. 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED WATERMELON SEEDING COULD NOT BE DETERMINED HOWEVER THE REPORTED KINKS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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, INCLUDING AT THE POINT THAT THE PRODUCT IS INSERTED INTO THE DISPENSER COIL. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A 100% RESTENOSED NON-ABBOTT STENT IN THE LEFT ANTERIOR DESCENDING ARTERY, THE 2.0 X 15 MM MINI TREK WAS USED AND INFLATED APPROXIMATELY 5 OR 6 TIMES AT 14 ATMOSPHERE WITHOUT ISSUE. IT WAS NOTED THAT THE BALLOON WATERMELON SEEDED PROXIMAL DURING A COUPLE OF THE INFLATION ATTEMPTS WITHOUT ISSUE. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE SHAFT HAD SEVERAL KINKS AT THE FLEX SHAFT JUNCTION NEAR THE GUIDE WIRE EXIT NOTCH. THE PHYSICIAN DID NOT AGGRESSIVELY USE THE DEVICE AND HE DID NOT NOTICE THE KINKS. A NON-ABBOTT STENT WAS PLACED INSIDE THE RESTENOSED NON-ABBOTT STENT. THERE WAS NO REPORTED PATIENT EFFECT. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0120661

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR