MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Device Problem Power Problem (3010)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.An angiojet ultra console was selected for use in a thrombectomy procedure.However, the console could not be powered on.The system stayed black and the door remained open.The procedure was cancelled.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use in a thrombectomy procedure.However, the console could not be powered on.The system stayed black and the door remained open.The procedure was cancelled.It was further reported that local anesthesia was used.The procedure was completed with a non-bsc device.

Manufacturer Narrative

Device eval by mfr: the console was received, and analysis completed.The angiojet console failed the functional feature test.The machine was unable to turn on due to a faulty ui display.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use in a thrombectomy procedure.However, the console could not be powered on.The system stayed black and the door remained open.The procedure was cancelled.It was further reported that local anesthesia was used.The procedure was completed with a non-bsc device.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• 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: 19181763
• MDR Text Key: 341404371
• Report Number: 2124215-2024-24823
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1