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	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension, diabetes mellitus (dm) and post covid.Recent increased shortness of breath brought to ed and then admitted.Procedure: percutaneous transluminal coronary angioplasty.Upon removal of catheter from the package, the scrubber was unable to disengage, unable to prep catheter.Not used on the 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; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14218016
• Report Number: 14218016
• Device Sequence Number: 4213064
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: (01)08714729904762(17)240308(10)29010898
• 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): 04/19/2022
• Report Date (Section F): 04/19/2022

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: 29010898
• 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: 04/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2022
• 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 Sex: Male
• Date Report Sent to FDA: 04/19/2022