BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2071172 · Received April 27, 2011

    Report

    Report Number
    2024168-2011-02960
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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 BLOOD VISIBLE ON THE SHAFT AND CONTRAST IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN, CONSISTENT WITH PREPARATION AND USE OF THE CATHETER. 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 WATER WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE WITH NO ANOMALIES NOTED. THE INFLATION TIMES OF THE BALLOON WERE ALSO MEASURED AND MET MANUFACTURING CRITERIA. IT WAS REPORTED THE DISTAL END OF THE BALLOON DID NOT INFLATE AND THERE WAS A BUBBLE NOTED. IT SHOULD BE NOTED 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. 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 SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THERE WAS ONE STILL IMAGE THAT SHOWED A BALLOON INFLATED ON A WIRE. THERE WAS AIR VISIBLE IN THE DISTAL 1/3RD OF THE BALLOON. THE REVIEWER CONCLUDED THAT FROM THE INCIDENT DESCRIPTION IT IS ASSUMED THAT THE PICTURE IS OF THE 3RD BALLOON INFLATION. THIS WOULD CONFIRM THAT THERE IS AIR (A BUBBLE) IN THE BALLOON. THE MOST LIKELY REASON FOR AIR IN A BALLOON IS THAT THE BALLOON PREPARATION WITH DILUTED CONTRAST WAS INCOMPLETE, LEAVING SOME AIR IN THE INFLATION LUMEN.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PROXIMAL CIRCUMFLEX ARTERY, THE RX MINI TREK DILATATION CATHETER WAS ADVANCED TO THE LESION. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 3 ATMOSPHERES (ATM) AND THE DISTAL END OF THE BALLOON DID NOT INFLATE. WATERMELON SEEDING OCCURRED PROXIMALLY. THE BALLOON WAS REPOSITIONED AND THE BALLOON WAS FULLY INFLATED AT 10 ATM. DURING THE THIRD INFLATION AT 8 ATM, A BUBBLE WAS SEEN INSIDE THE BALLOON. DILATATION WAS COMPLETED AND THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY. A 2.5 X 28 MM MULTI-LINK VISION STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO 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 0120761

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR