BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? 018

    MDR report key: 3122924 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03515
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    ITX
    PMA / PMN Number
    K073623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. ALL INVESTIGATION PROCEDURES AND TESTING, INCLUDING DECONTAMINATION WERE PERFORMED. THE DISTAL TIP WAS OBSERVED TO BE SEPARATED AT THE DISTAL END OF THE RO MARKER WHEN THE CATHETER WAS RECEIVED. THE TIP APPEARS TO HAVE BEEN STRETCHED AND ELONGATED 0.5CM. THE SEPARATED TIP IS NOT BRITTLE. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PREPARATION ON PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY, THE DISTAL TIP OF THE DEVICE WAS DETACHED. THE 90% STENOSED MODERATE TORTUOSITY AND CALCIFIED TARGET LESION WAS LOCATED AT THE RIGHT SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION WHEN THE PHYSICIAN UNPACKED THE F/G ATLANTIS 018 40MHZ AND LOAD THE IMAGING CATHETER UNTO A NON-BSC GUIDEWIRE. THE DISTAL TIP OF THE CATHETER DETACHED. THE PHYSICIAN STATED THAT THERE WAS NO RESISTANCE WHEN THE TIP DETACHMENT OCCURRED. THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PREPARATION ON PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY, THE DISTAL TIP OF THE DEVICE WAS DETACHED. THE 90% STENOSED MODERATE TORTUOSITY AND CALCIFIED TARGET LESION WAS LOCATED AT THE RIGHT SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION WHEN THE PHYSICIAN UNPACKED THE F/G ATANTIS 018 40MHZ AND LOAD THE IMAGING CATHETER UNTO A NON-BSC GUIDEWIRE. THE DISTAL TIP OF THE CATHETER DETACHED. THE PHYSICIAN STATED THAT THERE WAS NO RESISTANCE WHEN THE TIP DETACHMENT OCCURRED. THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224088 ATLANTIS? 018 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC - FREMONT (SUD) M001FG000240 15820211

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: DESTINATION| GUIDEWIRE: TREASURE