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

Model Number	8864
Medical Device Problem Code	Application Network Problem (2879)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that network failure occurred.The target lesion was located in the coronary artery.A 220v ce ilab ultrasound imaging system was used.Prior the procedure, the physician found a network failure in the equipment system.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention 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: 10277156
• Report Number: 2134265-2020-09325
• Device Sequence Number: 19454144
• Product Code: DQK
• UDI-Device Identifier: 08714729780205
• UDI-Public: 08714729780205
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 0000008142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1