BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 1990637 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00163
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. BLOOD WAS VISIBLE IN THE LUMEN OF THE DEVICE. THE DISTAL TIP WAS COMPLETELY SEPARATED AT THE END OF THE BRAID AND THE UNBRAIDED LENGTH WAS NOT RETURNED FOR ANALYSIS. THE BOND THAT ATTACHES THE DISTAL TIP TO THE END OF THE SHAFT WAS INTACT AND THERE WAS NO EVIDENCE OF A DEFICIENT BOND OR ANY MATERIAL OR MANUFACTURING IRREGULARITIES AT THE FRACTURE SURFACE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A CATHETER TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 6F MACH 1 FR4 GUIDE CATHETER WAS ADVANCED, FOLLOWED BY A 4.0X12MM QUANTUM APEX BALLOON CATHETER FOR DILATION. THE PHYSICIAN INFLATED THE QUANTUM APEX BALLOON TO 16ATMS AT THE MACH 1 CATHETER TIP. THIS CAUSED THE BALLOON TO SNAG THE CATHETER AND DISLODGE THE TIP OF THE MACH 1 GUIDE. THE TIP REMAINED OVER A GUIDE WIRE. THE PHYSICIAN THEN ADVANCED THE BALLOON CATHETER THROUGH THE TIP AND PARTIALLY INFLATED THE BALLOON RETRIEVING THE TIP BACK TO THE ACCESS SITE. THE TIP WAS THEN SNARED OUT FROM THERE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MACH 1 FR4 GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE THROUGHOUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A CATHETER TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 6F MACH 1 FR4 GUIDE CATHETER WAS ADVANCED, FOLLOWED BY A 4.0X12MM QUANTUM APEX BALLOON CATHETER FOR DILATION. THE PHYSICIAN INFLATED THE QUANTUM APEX BALLOON TO 16 ATMS AT THE MACH 1 CATHETER TIP. THIS CAUSED THE BALLOON TO SNAG THE CATHETER AND DISLODGE THE TIP OF THE MACH 1 GUIDE. THE TIP REMAINED OVER A GUIDE WIRE. THE PHYSICIAN THEN ADVANCED THE BALLOON CATHETER THROUGH THE TIP AND PARTIALLY INFLATED THE BALLOON RETRIEVING THE TIP BACK TO THE ACCESS SITE. THE TIP WAS THEN SNARED OUT FROM THERE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MACH 1 FR4 GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74934356020 0050557377

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention QUANTUM APEX MR 12MM X 4.00MM BALLOON CATHETER