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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) GALAXY INTRAVASCULAR ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BOSTON SCIENTIFIC - FREMONT (SUD) GALAXY INTRAVASCULAR ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number H749A70200
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
 
Event Description
Same case as 2134265-2018-00728 and 2134265-2018-00660.It was reported that automatic pullback failure occurred.The 75% stenosed target lesion was located in a mildly tortuous and non-calcified mid left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and a pullback sled to view the target lesion.However, during preparation of the opticross imaging catheter, the ilab froze on the connection confirmation screen and it was unable to perform pullback.Thus, automatic pullback failure occurred.The ilab did not start up properly even after it was tried to start after turning off.After the opticross imaging catheter was replaced with a non bsc catheter.The ilab main switch was turned off/on the issue was resolved.No patient complications were reported.
 
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Brand Name
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (SUD)
47215 lakeview blvd phone
west dock
fremont CA 94538
Manufacturer (Section G)
BOSTON SCIENTIFIC - FREMONT (SUD)
47215 lakeview blvd phone
west dock
fremont CA 94538
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7237037
MDR Text Key98884299
Report Number2134265-2018-00847
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K980851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH749A70200
Device Catalogue NumberA7020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2018
Initial Date FDA Received02/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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