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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 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Same case as mdr id# 2134265-2018-01710 and 2134265-2018-01711.It was reported that automatic pullback failure occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled.During a percutaneous coronary intervention (pci) procedure, the pullback sled didn¿t perform the pullback smoothly when auto pullback was on.The physician tried to initiate the automatic pullback but it failed.The procedure was completed with another of same device.No patient complications were reported and the patient was safe.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Device analysis revealed the sled was returned on overall good physical condition.Sled was able to properly connect to the motor drive unit 5+ (mdu5+).During functional testing using a test catheter, the sled was able to properly pull back and performed within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
 
Event Description
Same case as mdr id# 2134265-2018-01710 and 2134265-2018-01711.It was reported that automatic pullback failure occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled.During a percutaneous coronary intervention (pci) procedure, the pullback sled didn¿t perform the pullback smoothly when auto pullback was on.The physician tried to initiate the automatic pullback but it failed.The procedure was completed with another of same device.No patient complications were reported and the patient was safe.
 
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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 Key7296482
MDR Text Key101121974
Report Number2134265-2018-01495
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K980851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/09/2018
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 Expiration Date09/28/2018
Device Model NumberH749A70200
Device Catalogue NumberA7020
Device Lot NumberS1004939
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2018
Initial Date FDA Received02/26/2018
Supplement Dates Manufacturer Received04/02/2018
Supplement Dates FDA Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2017
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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