MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7495181160
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of cad (coronary artery disease).Procedure: heart cath with pci (percutaneous coronary intervention).The motor malfunctioned and would not work.Another one used without incident.No known harm to patient.Manufacturer response for catheter, ultrasound, intravascular, opticross 6 (per site reporter).Will obtain.

• Brand Name: OPTICROSS 6
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 17457973
• Report Number: 17457973
• Device Sequence Number: 15263007
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: (01)08714729904762(17)250614(10)31803839
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/28/2023
• Report Date (Section F): 07/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: H7495181160
• Device Lot Number: 31803839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 89 KG
• Date Report Sent to FDA: 07/28/2023