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

Model Number	H7493932800180
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that entanglement occurred.The 90% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery.An opticross 18 vascular imaging catheter was selected for use.During device pullback, it was reported that the unknown guidewire became wrapped around the opticross catheter mid-shaft, rendering the catheter non-functional.The device was removed intact, and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection found no issues with the device, it appears to be in good condition.Microscopic inspection of the guidewire exit port, and the tip were found damaged (deformed/lifted).Based on the evidence, the reported allegation of guidewire entanglement was confirmed, since the damage found during product analysis could have contributed to the reported codes.
Event or Problem Description
It was reported that entanglement occurred.The 90% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery.An opticross 18 vascular imaging catheter was selected for use.During device pullback, it was reported that the unknown guidewire became wrapped around the opticross catheter mid-shaft, rendering the catheter non-functional.The device was removed intact, and the procedure was completed with a different device.No patient complications were reported.It was further reported that the ivus catheter twisted on itself and trapping the non-boston scientific wire within it.The catheter and the wire were removed from patient as one unit.

• 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: 20968348
• Report Number: 2124215-2024-80098
• Device Sequence Number: 8447392
• 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): 01/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: H7493932800180
• Device Catalogue Number: H7493932800180
• Device Lot Number: 0035268658
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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