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

Model Number	44021
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entanglement occurred.The totally occluded target lesion was located in the non-tortuous and moderately calcified mid to distal superficial femoral artery.An opticross 18 was selected for use.During the procedure, it was noted that the opticross wrapped around the non-boston scientific wire.The wire and catheter were removed, and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that device entanglement occurred.The totally occluded target lesion was located in the non-tortuous and moderately calcified mid to distal superficial femoral artery.An opticross 18 was selected for use.During the procedure, it was noted that the opticross wrapped around the non-boston scientific wire.The wire and catheter were removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual and microscope inspections were performed.Twists were observed in the imaging window assembly.No other issues were identified with the device and 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: 20626381
• Report Number: 2124215-2024-67345
• Device Sequence Number: 20716453
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: 08714729904366
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 07/02/2026
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0034362047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: ABBOTT SPARTACORE; GUIDEWIRE: ABBOTT SPARTACORE
• Patient Sex: Unknown