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

Model Number	8864
Medical Device Problem Codes	Poor Quality Image (1408); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A capital equipment ilab ultrasound imaging system was selected for use.During procedure, a first run was successfully performed.When a second was attempted, no image was displayed.The mdu5+ component seemed to work but the image was black.The procedure was cancelled due to this event.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacture: the device was not returned for analysis; however, a capital equipment technical fse (field service engineer) visited the site to investigate the reported issue with ilab system.Fse reinstalled polaris 2.12 using dvd and performed several runs one after the other successfully.Console worked properly according to boston scientific specifications.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18614851
• Report Number: 2124215-2024-04979
• Device Sequence Number: 7565205
• Product Code: DQK
• UDI-Device Identifier: 08714729777694
• UDI-Public: 08714729777694
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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: 0000007920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown