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

Model Number 8864

Device Problems Poor Quality Image (1408); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 335086959
• Report Number: 2124215-2024-04979
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729777694
• UDI-Public: 08714729777694
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1