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

Model Number	H74939352040
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the tip broke off in the patient.There was no patient complications reported.
Additional Manufacturer Narrative
Good faith effort attempts are being made to try and retrieve additional details regarding the reported event, but further information has not been obtained.B3: date of event: the event date was not reported.The first date of the month of the aware date was entered as an estimate.G4: premarket/510(k) #: k213593.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the tip broke off in the patient.There was no patient complications reported.
Additional Manufacturer Narrative
B3: date of event: the event date was not reported.The first date of the month of the aware date was entered as an estimate.G4: premarket / 510(k) #: k213593.Investigation results: device analysis findings: the device was returned for analysis.Visual inspection revealed the sheath assembly was observed kinked.Microscopic inspection revealed the guidewire exit port was torn, but the distal section of the tip was in good condition.The functional test showed a test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter.Device history record (dhr) review: it was confirmed that this device met manufacturing specifications before distribution and there were no manufacturing deviations that could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of device problem excluded following a review of the returned device, reported event details, available information, and product record review.In this case, the device performed as intended during the analysis, and no damage was found that could have contributed to the reported allegation.Regarding the torn exit port, this occurs due to friction between the edges of the exit port and the guidewire.This friction could be found during advancement of the device into patient's anatomy due to the lesion characteristics, caused by the maneuvers of the user which could lead to an excessive friction that deforms the material.Since the device met all manufacturing specifications, it is most probable that the issue occurred during the procedure.Therefore, adverse event related to procedure is the assigned cause for the torn exit port.

• 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: 23970027
• Report Number: 2124215-2026-00514
• Device Sequence Number: 18110003
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)260808(10)37168929
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 08/08/2026
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0037168929
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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