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

Model Number	H7493932800180
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k160514, k222568.
Event or Problem Description
It was reported that device contamination occurred.An opticross 18 was selected for use.However, it was noted that there was a hair (foreign matter) within the sterile packaging.The procedure was completed using another catheter.No patient complications were reported.
Event or Problem Description
It was reported that device contamination occurred.An opticross 18 was selected for use.However, it was noted that there was a hair (foreign matter) within the sterile packaging.The procedure was completed using another catheter.No patient complications were reported.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k160514, k222568.Device evaluated by mfr: the device was returned to our post market quality assurance laboratory.Visual inspection was performed, and no issues or foreign matter were observed in the returned package.No other issues were identified during the product analysis.

• 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: 21718960
• Report Number: 2124215-2025-16282
• Device Sequence Number: 3929008
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: (01)08714729904366(17)260927(10)34945442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/10/2025

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: 09/27/2026
• Device Model Number: H7493932800180
• Device Catalogue Number: H7493932800180
• Device Lot Number: 0034945442
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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