BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2132812 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04313
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MINI TREK OTW DILATATION CATHETER NOTED BLOOD VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN AND CONTRAST ON THE SHAFT, CONSISTENT WITH PREPARATION AND A RUPTURE WHILE IN THE PATIENT ANATOMY. THE SHAFT WAS BUNCHED SPORADICALLY 4.8 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL, FOR A LENGTH OF 2.4 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BUNCHED SHAFT 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 BALLOON RUPTURE. A NEW INDEFLATOR FILLED WITH WATER WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP), WHEN IT WAS OBSERVED THAT FLUID WAS LEAKING FROM A LONGITUDINAL RUPTURE IN THE BALLOON 4 MM PROXIMAL TO THE BALLOON MARKER AND EXTENDING PROXIMALLY, FOR AN ENTIRE LENGTH OF 8 MM. THERE WERE NO SCRATCHES FOUND. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THE BALLOON FAILURE MAY BE RELATED TO EXPOSURE CONDITIONS OR A MATERIALS/PROCESSING DISCREPANCY. NUMEROUS PARTIAL TEARS AND LONGITUDINAL LINES WERE OBSERVED ON THE INNER SURFACE AND AT THE RUPTURE EDGE. THIS TYPE OF FAILURE IS CONSISTENT WITH OVER-INFLATION OF THE BALLOON AS IT WAS REPORTED THE BALLOON WAS INFLATED TO 18 ATM. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CALCIFIED, TOTALLY OCCLUDED, MID RIGHT CORONARY ARTERY, THE 1.5 X 20 MM MINI TREK WAS INFLATED A THIRD TIME AND IT RUPTURED WHEN INFLATED TO 18 ATMOSPHERE (ATM). IT WAS NOTED THAT THE SHAFT WITHIN THE BALLOON WAS DAMAGED (BROKEN). A SECOND MINI TREK WAS USED IN THE PROCEDURE WITH A GOOD RESULT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 0111161

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: ASAHI COFIANZA