BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BX SONIC 3.50 X 18 MM

    MDR report key: 1833396 · Received September 14, 2010

    Report

    Report Number
    9616099-2010-00683
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15072270 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT A HUB CRACK WAS NOTED DURING INFLATION OF THE STENT DELIVERY BALLOON. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS DESCRIBED AS 80% STENOSED, BOTH MODERATELY CALCIFIED AND TORTUOUS AND ANGLED. THERE WERE NO ANOMALIES NOTED PRIOR TO USE AND THE DEVICE PREPPED ACCORDING TO IFU. A MEDTRONIC INDEFLATOR WAS USED. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE 3.50MM X 18MM BX SONIC STENT AND THE DEVICE WAS TORQUED BY THE HUB. THE DEVICE WAS ADVANCED WITH THE INDEFLATOR CONNECTED TO THE HUB. AT 10 ATM, THE DOCTOR NOTED THAT THE BALLOON WAS NOT INFLATING AND A LEAK AND A CRACK WERE OBSERVED AT THE HUB ITSELF. THE DEVICE WAS REMOVED BY PULLING THE DEVICE INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED, WITH THE STENT, WITHOUT COMPLICATIONS OR RESISTANCE. THE PATIENT WAS TREATED WITH ANOTHER BX SONIC OF THE SAME SIZE. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR EVALUATION. ADDENDUM RECEIVED 10/22/2010: WHEN THE DEVICE WAS RECEIVED IT WAS SEPARATED IN TWO AT 21CM FROM STRAIN AND HAD BENDS THROUGHOUT. THE QUALRAP CONFIRMED THIS HAPPENED DURING THE PROCEDURE. ONE NON STERILE BX SONIC WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE UNIT WAS RECEIVED IN TWO SECTIONS; IT WAS BROKEN AT 117CM FROM DISTAL END. THE DISTAL SECTION WAS KINKED AT 100.3C, 105.5CM, 107.7CM, AND 116.5CM FROM DISTAL END. PROXIMAL SECTION WAS KINKED AT 19.7CM, 21.7CM, 23CM, AND 24CM FROM PROXIMAL END. THE STENT WAS CRIMPED AND MOUNTED BETWEEN MARKER BANDS; IT DID NOT SHOW ANY DAMAGE. THE HUB DID NOT PRESENT DAMAGES. DURING MICROSCOPIC ANALYSIS WAS OBSERVED THAT THE SECTION WHERE THE SHAFT GOT BROKEN APPEARS AS IF IT HAD BEEN KINKED BEFORE IT GOT BROKEN. PRESSURIZED WATER WAS INJECTED AND NO LEAKS OR CRACKS WERE OBSERVED AT THE HUB, WATER LEAK WAS NOTED AT THE SEPARATED END. CROSSING PROFILE OF THE STENT WAS FOUND WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED LUER HUB CRACK WAS NOT CONFIRMED; HOWEVER, KINKED BENT AND BODY/SHAFT SEPARATED WERE CONFIRMED THROUGH FAILURE ANALYSIS. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THAT POSSIBLE PROCEDURAL AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENTS. THERE IS NO INDICATION IN THE INFORMATION RECEIVED OR THE ANALYSIS TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING BALLOON INFLATION, IT WAS NOTED THAT THE HUB WAS CRACKED. THERE WERE NO ANOMALIES NOTED PRIOR TO USE AND THE DEVICE PREPPED ACCORDING TO IFU. A MEDTRONIC INDEFLATOR WAS USED. THE TARGET LESION WAS THE MID LAD. THE LESION WAS MODERATELY CALCIFIED AND THE VESSEL WAS MODERATELY TORTUOUS AND ANGLED. STENOSIS WAS 80%. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE PRODUCT AND THE DEVICE WAS TORQUED BY THE HUB. THE DEVICE WAS ADVANCED WITH THE INDEFLATOR CONNECTED TO THE HUB. AT 10 ATM, THE DOCTOR NOTED THAT THE BALLOON WAS NOT INFLATING AND A LEAK AND A CRACK WERE OBSERVED AT THE HUB ITSELF. THE DEVICE WAS REMOVED BY PULLING THE DEVICE INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED WITHOUT COMPLICATIONS OR RESISTANCE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDENDUM RECEIVED 10/22/2010: WHEN THE DEVICE WAS RECEIVED IT WAS SEPARATED IN TWO AT 21CM FROM STRAIN AND HAD BENDS THROUGHOUT. THE QUALRAP CONFIRMED THIS HAPPENED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC 3.50 X 18 MM CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO 15072270

    Patients

    Seq Age Sex Outcome Treatment
    1