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

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that a device issue occurred resulting in an aborted procedure.An ilab ultrasound imaging system was used for intravascular ultrasound (ivus) examination of the target lesion.During the ivus procedure, the physician found that the motor could not identify the catheter.The procedure was not completed due to this event and was rescheduled.The patient was stable and no complications were reported.

Event Description

It was reported that a device issue occurred resulting in an aborted procedure.An ilab ultrasound imaging system was used for intravascular ultrasound (ivus) examination of the target lesion.During the ivus procedure, the physician found that the motor could not identify the catheter.The procedure was not completed due to this event and was rescheduled.The patient was stable and no complications were reported.It was further reported that the patient was already sedated with local anesthesia when the issue occurred.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18677260
• MDR Text Key: 335949175
• Report Number: 2124215-2024-07527
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1