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

Model Number	H749518100
Medical Device Problem Codes	Nonstandard Device (1420); Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.An opticross imaging catheter was selected for use in the ultrasound examination.During preparation, it was noted that there was a hole in the guidewire cavity of the catheter and the guidewire entered the internal cavity through this hole.The procedure was completed with another of the same device.The patient condition following the procedure was stable.
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.E1: initial reporter phone: (b)(6).
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.E1: initial reporter phone: (b)(6).H6 device codes: corrected.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross imaging catheter was selected for use in the ultrasound examination.During preparation, it was noted that there was a hole in the guidewire cavity of the catheter and the guidewire entered the internal cavity through this hole.The procedure was completed with another of the same device.The patient condition following the procedure was stable.
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.E1: initial reporter phone: (b)(6).Investigation results: device analysis findings: the device was returned for analysis.Visual inspection revealed sheath was observed bent.Microscopic inspection showed that the guidewire exit port and the distal section of the tip were in good condition.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.Review of the returned device, reported event details, available information, and product records confirmed that the device performed as intended and no damage was identified that could have contributed to the reported allegation.Regarding the observed bent sheath, this type of condition is often caused by external forces over the material, such as bending forces that may be encountered during handling of the device outside the patient, including device unpacking or preparation.Since the device met all manufacturing specifications, it is most probable that the observed bent occurred during these activities; therefore, adverse event related to procedure is the assigned cause for the observed bent sheath.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross imaging catheter was selected for use in the ultrasound examination.During preparation, it was noted that there was a hole in the guidewire cavity of the catheter and the guidewire entered the internal cavity through this hole.The procedure was completed with another of the same device.The patient condition following the procedure was stable.

• Brand Name: OPTICROSS
• 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: 23990966
• Report Number: 2124215-2026-00954
• Device Sequence Number: 13392493
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260908(10)37402141
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123621
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 09/08/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037402141
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/20/2026; 03/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 72 KG