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

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

It was reported that motor drive overload occurred and the catheter could not be recognized.An ilab ultrasound imaging system was selected to be used for a procedure.Prior to the procedure, the opticross catheter could not be recognized because of a motor drive overload error.The procedure was unable to be completed due to this event and it was unknown if the patient was sedated.The patient was stable and no patient complications occurred.

Manufacturer Narrative

Device evaluated by mfr.: the mdu-5 plus was received in good conditions.The reported complaint was not confirmed.The unit passed the mdu-5 plus basic functional test.No error messages were observed during the test.In addition, the unit successfully passed image and pullback test.

Event Description

It was reported that motor drive overloaded and the catheter could not be recognized.An ilab ultrasound imaging system was selected to be used for a procedure.Prior to the procedure, the opticross catheter could not be recognized because of a motor drive overload error.The procedure was unable to be completed due to this event and it was unknown if the patient was sedated.The patient was stable and no patient complications occurred.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10094131
• MDR Text Key: 192389180
• Report Number: 2134265-2020-07089
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 11/02/2020
• Patient Sequence Number: 1