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

Model Number	H74939352040
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sheath detachment occurred.During a post-pci ivus run, it was determined that the opticross hd had separated internally, the outer sleeve remained in the vessel while the inner sleeve was near the catheter-sled connection.The procedure was completed with an alternate device with no reported adverse outcome.
Additional Manufacturer Narrative
G4 premarket / 510(k) #: k213593.
Event or Problem Description
It was reported that sheath detachment occurred.During a post-pci ivus run, it was determined that the opticross hd had separated internally, the outer sleeve remained in the vessel while the inner sleeve was near the catheter-sled connection.The procedure was completed with an alternate device with no reported adverse outcome.
Additional Manufacturer Narrative
G4 premarket / 510(k) #: k213593 device evaluated by manufacturer: the returned device presented no damage, and the device appears to be in good condition.Inspection of the remainder of the device presented no other damage or irregularities.The reported complaint is not confirmed.

• Brand Name: OPTICROSS? HD
• 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 ; 7634941632
• MDR Report Key: 22057375
• Report Number: 2124215-2025-32450
• Device Sequence Number: 8308808
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)260129(10)35738629
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 01/29/2026
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0035738629
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/13/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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