BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2073190 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03024
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 2, 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
    JA
    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. GUIDE WIRE: RUNTHROUGH. GUIDE CATH: BRIGHT TIP JL35. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE BALLOON, CONSISTENT WITH A SEPARATION WHILE IN THE PATIENT ANATOMY. THERE WAS BLOOD ON THE SHAFT. THE BALLOON WAS SEPARATED AT THE PROXIMAL SEAL AND INVERTED OVER THE TIP. THIS DAMAGE MAY BE WHAT WAS PERCEIVED BY THE ACCOUNT AS THE TIP DETACHED AND DAMAGED AS THE BALLOON WAS FOLDED OVER THE TIP, APPEARING AS IF THE TIP WAS DETACHED. THE FRACTURE FACE WAS STRETCHED AND JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THERE WERE TWO BENDS IN THE DISTAL SHAFT 5 CM AND 15 CM PROXIMAL TO THE PROXIMAL MARKER. THERE WERE MULTIPLE BENDS AND KINKS IN ENTIRE LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE BALLOON CATHETER WAS ATTEMPTED TO ADVANCE THROUGH THE STRUTS OF A PREVIOUSLY PLACED STENT, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AS THE CATHETER WAS ATTEMPTED TO ADVANCE THROUGH THE STENT STRUTS, THE BALLOON INTERACTED WITH THE STENT STRUTS, BECOMING CAUGHT UP, SUCH THAT DURING REMOVAL OF THE CATHETER FROM THE STENT STRUTS, THE BALLOON SEPARATED FROM THE PROXIMAL SEAL AND FOLDED OVER THE TIP. 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 FAILURE TO ADVANCE, TIP DETACHMENT, OR BALLOON SEPARATIONS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE AND NOTED BALLOON SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX (CX) LESION. A NON-ABBOTT STENT WAS DEPLOYED IN THE SIDE BRANCH OF THE LEFT CX AND LEFT ANTERIOR DESCENDING ARTERY. THE TREK BALLOON WAS ADVANCED TO THE SIDE BRANCH THROUGH THE STENT STRUTS; HOWEVER, THE TREK WOULD NOT CROSS THE LESION. IT WAS OBSERVED THAT AFTER REMOVAL, THE TIP OF THE BALLOON CATHETER WAS WRINKLED. DURING HANDLING OF THE TREK, OUTSIDE THE ANATOMY, THE TIP DETACHED FROM THE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS CONFIRMED THAT THE TIP WAS NOT SEPARATED; HOWEVER, THE BALLOON WAS DETACHED AT THE PROXIMAL SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0080961

    Patients

    Seq Age Sex Outcome Treatment
    1