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

Model Number 105650-001H

Device Problem Failure to Shut Off (2939)

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

Event Date 01/04/2021

Event Type  malfunction  

Event Description

System error 60: unable to power off actuator.Manufacturer response for angiojet, possis medical (per site reporter).Unable to receive further information requested from the manufacturer on root cause to help prevent this from potentially happening again and causing patient incident.Sending final email and including fda contact, and also closing out fda report.Will attach any later documentation to this work order if received from bsci or fda.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12266741
• MDR Text Key: 264915758
• Report Number: 12266741
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2021,01/05/2021

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: No Information
• Device Model Number: 105650-001H
• Device Catalogue Number: 105650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1