MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 8878

Device Problem Image Display Error/Artifact (1304)

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

Event Date 01/31/2024

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, during ivus runs the vessel image did not show once inside the patient.The procedure was cancelled due to this event.There were no patient complications reported.

Manufacturer Narrative

B5 describe event or problem: updated.H6 impact codes: replaced by f26: no health consequences or impact.

Event Description

It was reported that the procedure was cancelled.A capital equipment ilab ultrasound imaging system was selected for use.During procedure, during ivus runs the vessel image did not show once inside the patient.The procedure was cancelled due to this event.There were no patient complications reported.It was further reported that there was no patient sedation or anaesthesia.The above percutaneous coronary intervention (pci) procedure was completed without using ivus and everything was fine.The motordrive unit was replaced and that has resolved the problem.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18761477
• MDR Text Key: 336960216
• Report Number: 2124215-2024-10489
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 8878
• Device Catalogue Number: 8878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/11/2024
• 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: Reuse
• Patient Sequence Number: 1