MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800180
Medical Device Problem Codes	Entrapment of Device (1212); Poor Quality Image (1408); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used 10/01/2024 as the event date was not reported.G4: premarket/510(k) #: k160514, k222568.
Event or Problem Description
It was reported that catheter issue occurred.An opticross 18 imaging catheter was selected for use.However, it was noted that the device could not provide imaging beyond a grainy background screen from the beginning.Subsequently, the device experienced a power overload, causing the catheter to wrap around the guidewire when the imaging was stopped.An attempt to unplug and reconnect to the motor drive unit (mdu) was performed, but the issue persisted.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information b3 - date of event: used 10/01/2024 as the event date was not reported.G4 - premarket / 510(k) #: k160514, k222568.
Event or Problem Description
It was reported that catheter issue occurred.An opticross 18 imaging catheter was selected for use.However, it was noted that the device could not provide imaging beyond a grainy background screen from the beginning.Subsequently, the device experienced a power overload, causing the catheter to wrap around the guidewire when the imaging was stopped.An attempt to unplug and reconnect to the motor drive unit (mdu) was performed, but the issue persisted.It was further reported that the procedure was completed using another opticross 18.Moreover, the patient was doing well post-procedure.

• Brand Name: OPTICROSS 18
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20711840
• Report Number: 2124215-2024-68940
• Device Sequence Number: 9604314
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: 08714729904366
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Expiration Date: 03/06/2026
• Device Model Number: H7493932800180
• Device Catalogue Number: H7493932800180
• Device Lot Number: 0033574958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown