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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 01/30/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
 
Event Description
Same case as: 2134265-2018-01358 and 2134265-2018-01127.It was reported that automatic pullback failure occurred.A 120v ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During the procedure, pullback was performed, however, pullback failed.A message "pdaq error=motor overload" was displayed.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 Key7260299
MDR Text Key99945703
Report Number2134265-2018-01357
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 01/30/2018
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 01/30/2018
Initial Date FDA Received02/09/2018
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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