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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number H749ILAB240CART0
Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2015
Event Type  malfunction  
Event Description
Same case as: 2134265-2015-02446, 2134265-2015-02447, 2134265-2015-02448, 2134265-2015-02604.It was reported that automatic pullback failure occurred.A motor drive unit (mdu) was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled to view an unspecified target lesion.It was noted before the procedure that the system randomly fails to boot up, stopping at the bios checking before the operative system loading then after a power cycle the system works fine again.Then it was also noted that the physician could not execute automatic pullback.The physician decided to change the sled and the catheter but problem still persisting and had to perform it manually.They are facing the exact same issue they had a couple of weeks ago with the automatic pullback in which they replaced the mdu at that time.No patient complications were reported and patient's condition is stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The products were received in good condition with no visible damage observed.Acquisition pc and mdu5 plus meets specifications of the ilab system functional feature test and the mdu5 qc functional test respectively.However, the image pc failed the specification of the ilab system functional feature test.The cause of the image failure was due to it's pc power supply socket.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
 
Event Description
Same case as: 2134265-2015-02446, 2134265-2015-02447, 2134265-2015-02448, 2134265-2015-02604.It was reported that automatic pullback failure occurred.A motor drive unit (mdu) was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled to view an unspecified target lesion.It was noted before the procedure that the system randomly fails to boot up, stopping at the bios checking before the operative system loading then after a power cycle the system works fine again.Then it was also noted that the physician could not execute automatic pullback.The physician decided to change the sled and the catheter but problem still persisting and had to perform it manually.They are facing the exact same issue they had a couple of weeks ago with the automatic pullback in which they replaced the mdu at that time.No patient complications were reported and patient's condition is stable.
 
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Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
Manufacturer (Section G)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4735000
MDR Text Key5822725
Report Number2134265-2015-02445
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K051679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 04/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH749ILAB240CART0
Device Lot Number0000004682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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