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

Model Number	44021
Medical Device Problem Codes	Entrapment of Device (1212); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.The 70% stenosed target lesion was located with a 50% tortuosity and 80% calcified superficial femoral artery.The opticross 18 imaging catheter was selected for ultrasound examination of the target lesion.When live imaging was turned on while outside the patient`s body, the strong vibration between the wire and the transducer had caused the wire to tangle around the catheter and the image on the ilab console was black.They stop the live imaging immediately.They removed the catheter and re flushed but the image was still black.The procedure was completed using an alternate device.No patient complications were reported.

• 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: 19751156
• Report Number: 2124215-2024-43398
• Device Sequence Number: 21083843
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: 08714729904748
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K160514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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: 11/21/2025
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0032909012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/16/2024
• Date Device Manufactured: 11/22/2023
• 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