BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2182417 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05347
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, IT WAS REPORTED THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE RESISTANCE. AS THE CATHETER WAS EVENTUALLY ABLE TO CROSS THE LESION, THE REPORTED PHYSICAL RESISTANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES 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. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE. RETURN OF THE RX MINI TREK CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE HEAVILY CALCIFIED AND TOTALLY OCCLUDED LESION SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 12 ATMOSPHERES WHICH IS BELOW THE RATED BURST PRESSURE. 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. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC DEFICIENCY. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE REPORTED BALLOON RUPTURE AND PHYSICAL RESISTANCE APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION BLUE, RUNTHROUGH. GUIDE CATH: TAIGA. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE DISTAL RIGHT CORONARY ARTERY, WITH A VESSEL DIAMETER OF 2.5 MM, AND A LESION LENGTH OF 28 MM. THE VESSEL WAS MODERATELY TORTUOUS AND HEAVILY CALCIFED, WAS CONCENTRIC, DE NOVO, WITH A 99% STENOSIS. AFTER A NON-ABBOTT GUIDE WIRE CROSSED THE LESION, THE 1.20 X 6 MM TREK WAS ADVANCED; HOWEVER, ON THE FIRST INFLATION TO NOMINAL PRESSURE (8 ATMOSPHERES FOR 30 SECONDS), THE BALLOON RUPTURED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE BALLOON CATHETER; HOWEVER, THERE WAS NO RESISTANCE REPORTED DURING RETRACTION OF THE CATHETER FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT ADVERSE EFFECTS WERE REPORTED. 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 1022161

    Patients

    Seq Age Sex Outcome Treatment
    1