BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1

    MDR report key: 8075430 · Received November 15, 2018

    Report

    Report Number
    2134265-2018-62946
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729351221
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. MFR SITE ADDRESS 2: 20905 INT.A.COL.,CD.INDUSTRIAL. DEVICE EVALUATED BY MFR: INVESTIGATION WAS COMPLETED. RETURNED PRODUCT CONSISTED OF A 6F MACH 1 GUIDE CATHETER, FOLDED MULTIPLE TIMES INSIDE THE POUCH. INSPECTION REVEALED NUMEROUS KINKS IN THE SHAFT, AND DAMAGE TO THE CARDBOARD BACKING (RELATIVE TO THE SHAFT KINKS). THE REPORTED DAMAGE (TAPE OPEN) TO THE BOX COULD NOT BE CONFIRMED AS THE BOX WAS NOT SENT BACK FOR ANALYSIS AND THERE WAS NO PHOTOS OF THE OPEN TAPE, BUT CAN LIKELY BE ATTRIBUTED TO HANDLING OF THE BOX. THE SHAFT DAMAGE (KINKS) AND TYVEK/CARDBOARD PACKAGING DAMAGE IS LIKELY ATTRIBUTED TO SHIPPING THE DEVICE BACK FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING SEAL WAS COMPROMISED. A MACH1 GUIDE CATHETER WAS SELECTED DURING A PATIENT PROCEDURE. THE PHYSICIAN FINISHED USING AN UNSPECIFIED DEVICE AND PLANNED TO REPLACE IT WITH THE 6F MACH1 DEVICE. HOWEVER, UPON VISUAL INSPECTION OF THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THE TAPE/SEAL WAS FOUND TO BE OPEN. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TAPE OF OUTER POUCH(BOX) WAS TORN AND LID OF OUTER POUCH(BOX) WAS OPENED. HOWEVER, THE INNER POUCH WAS NEITHER COMPROMISED NOR DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING SEAL WAS COMPROMISED. A MACH1 GUIDE CATHETER WAS SELECTED DURING A PATIENT PROCEDURE. THE PHYSICIAN FINISHED USING AN UNSPECIFIED DEVICE AND PLANNED TO REPLACE IT WITH THE 6F MACH1 DEVICE. HOWEVER, UPON VISUAL INSPECTION OF THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THE TAPE/SEAL WAS FOUND TO BE OPEN. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TAPE OF OUTER POUCH(BOX) WAS TORN AND LID OF OUTER POUCH(BOX) WAS OPENED. HOWEVER, THE INNER POUCH WAS NEITHER COMPROMISED NOR DAMAGED.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING SEAL WAS COMPROMISED. A MACH1 GUIDE CATHETER WAS SELECTED DURING A PATIENT PROCEDURE. THE PHYSICIAN FINISHED USING AN UNSPECIFIED DEVICE AND PLANNED TO REPLACE IT WITH THE 6F MACH1 DEVICE. HOWEVER, UPON VISUAL INSPECTION OF THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THE TAPE/SEAL WAS FOUND TO BE OPEN. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915179 MACH1 CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION 1260 0060142334 08714729351221

    Patients

    Seq Age Sex Outcome Treatment
    1