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

Model Number	H74939354080
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was in cath lab for inferior wall stemi [st-segment elevation myocardial infarction] and had 2 stents placed in rca [right coronary artery].The ivus [intravascular ultrasound] was used afterwards to ensure the stents were properly placed and deployed in the coronary artery.When ivus imaging was done the catheter could not be removed without also removing the guidewire at the same time.Ivus catheter and guidewire were removed together, as a single unit.It appears that ivus catheter got stuck on the wire.No harm to patient but could have potentially caused hard if a guidewire was still needed.

• Brand Name: OPTICROSS¿ 6 HD
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 21967920
• Report Number: 21967920
• Device Sequence Number: 15484523
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270122(10)35686233
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/28/2025
• Report Date (Section F): 04/28/2025

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 Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 35686233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/28/2025