MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800350
Medical Device Problem Codes	Material Perforation (2205); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: as the event date was not reported, the first day in the month of the aware date is provided d2b product code: obj, itx.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported the catheter was perforated by the guidewire.During use of the opticross 35 catheter, when being loaded over the amplatz wire, it perforated the side of the catheter.The device never entered the patient.No further information is available.

• Brand Name: OPTICROSS 35
• 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 first street, propark; el coyol, alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22917828
• Report Number: 2124215-2025-60740
• Device Sequence Number: 10107113
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: (01)08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: H7493932800350
• Device Catalogue Number: H7493932800350
• 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: 08/04/2025
• Initial Report FDA Received Date: 08/28/2025
• 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