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

Model Number	H7495181160
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 70¿s male with history of coronary artery disease and smoking.New onset of shortness of breath.Procedure: diagnostic heart cath and balloon angioplasty and percutaneous intervention x 2.When going into the vessel the first time, catheter folded back on itself several times causing twists and kinks deeming nonfunctioning.No known harm to patient.Device removed and another one used.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; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16627027
• Report Number: 16627027
• Device Sequence Number: 17476375
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: (01)08714729904762(17)250115(10)30860549
• 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): 03/16/2023
• Report Date (Section F): 03/16/2023

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: 30860549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 62 KG
• Date Report Sent to FDA: 03/16/2023