MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H749ILAB120CART0
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
Same case as: 2134265-2018-00109 and 2134265-2018-00110.It was reported that automatic pullback failure occurred.A 120v ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and a pullback sled to view the target lesion.During the procedure, it was noticed that motordrive unit does not pullback.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Device analysis revealed a very dirty lemo cable and defective clutch.When the pullback button was pressed, the unit did not move in the sled and showed the warning "215" which appeared when the clutch did not engage.By removing, the unit cases noted that the clutch gears were misaligned.The investigation conclusion isolated the failure to a specific component within a bsc system or assembly which contributed to the event; however the cause for the component failure is unknown.(b)(4).
Event or Problem Description
Same case as: 2134265-2018-00109 and 2134265-2018-00110.It was reported that automatic pullback failure occurred.A 120v ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and a pullback sled to view the target lesion.During the procedure, it was noticed that motordrive unit does not pullback.No patient complications were reported.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 7167141
• Report Number: 2134265-2017-13304
• Device Sequence Number: 1823011
• Product Code: OBJ
• UDI-Device Identifier: 08714729810032
• UDI-Public: 08714729810032
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K051679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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
• Operator of Device: Health Professional
• Device Model Number: H749ILAB120CART0
• Device Lot Number: 0000004372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1