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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number H749ILAB100C270
Device Problem Retraction Problem (1536)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a sled to perform automatic pullback.However, it was unable to perform pullback.Thus, automatic pullback failed.Furthermore, no problem was encountered during testing now.Recently, pullback often stops.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The product was received in good condition with no visible external damage or defects observed.The mdu-5plus was installed into a gold standard system and tested for functionality.The unit meets 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
It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a sled to perform automatic pullback.However, it was unable to perform pullback.Thus, automatic pullback failed.Furthermore, no problem was encountered during testing now.Recently, pullback often stops.No patient complications were reported.
 
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Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
MDR Report Key7756301
MDR Text Key116228374
Report Number2134265-2018-07088
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH749ILAB100C270
Device Catalogue NumberILAB100C27
Device Lot Number0000008532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2018
Date Manufacturer Received09/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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