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

Model Number	H7493932800180
Medical Device Problem Code	Material Integrity Problem (2978)
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 catheter issue occurred.The more that 90% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.An opticross 18 was advanced over a 018 thruway guidewire.However, the wire seemed to exit the monorail portion prematurely.It seemed that the device had separated from the main portion of the delivery shaft.There was no issue noted with the guidewire.The procedure was completed with another opticross 18 and the same thruway guidewire.No patient complications were reported.
Additional Manufacturer Narrative
G4 - additional premarket / 510(k): k222568.
Additional Manufacturer Narrative
G4 - additional premarket / 510(k): k222568.The device was returned for evaluation.Visual inspection revealed that no issues were found, the device appears to be in good conditions.No damages or failures were observed on the ccp (catheter code pcba) board assembly.Microscope inspection revealed that the guidewire exit port, and the tip were found damaged (deformed/lifted).The imaging window was twisted and deformed.The above-referenced calibrated equipment was used to perform an impedance test.The impedance test shows an electrical open distal waveform between 0-10 cm from the distal housing.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.The mdu and ilab system were used to perform a functional inspection on the device.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that catheter issue occurred.The more that 90% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.An opticross 18 was advanced over a 018 thruway guidewire.However, the wire seemed to exit the monorail portion prematurely.It seemed that the device had separated from the main portion of the delivery shaft.There was no issue noted with the guidewire.The procedure was completed with another opticross 18 and the same thruway guidewire.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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20947452
• Report Number: 2124215-2024-77936
• Device Sequence Number: 19961735
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: 08714729904366
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/12/2025

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 Expiration Date: 04/29/2026
• Device Model Number: H7493932800180
• Device Catalogue Number: H7493932800180
• Device Lot Number: 0033925944
• 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: 01/14/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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: Female
• Patient Weight: 79 KG
• Patient Race: White