MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8864
Medical Device Problem Codes	Retraction Problem (1536); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that automatic pullback failure occurred.A 100v ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.However, pullback was unable to be performed.Lost internal computer connection occurred.The ilab main switch was turned off/on and it restored temporarily, but the issue occurred again.No patient complications were reported.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7881363
• Report Number: 2134265-2018-61055
• Device Sequence Number: 16621552
• Product Code: DQK
• UDI-Device Identifier: 08714729761235
• UDI-Public: 08714729761235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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
• Operator of Device: Health Professional
• Device Model Number: 8864
• Device Catalogue Number: 8864
• Device Lot Number: 0000005632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/17/2018
• Patient Sequence Number: 1