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

Model Number	H749518100
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the coronary artery.An opticross imaging catheter was selected for use in the ultrasound examination.During the preparation, the catheter became entangled with the guidewire.The procedure was completed with another of the same device.There was no patient complications reported, and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).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 that catheter issue occurred.The target lesion was located in the coronary artery.An opticross imaging catheter was selected for use in the ultrasound examination.During the preparation, the catheter became entangled with the guidewire.The procedure was completed with another of the same device.There was no patient complications reported, and the patient was stable.It was further reported that the 50% stenosed target lesion was located in the non-tortuous and mildly calcified vessel and the catheter and guidewire were pulled out together as one unit.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Investigation results: device analysis findings: device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed no issues were found, and the device appears to be in good condition.Microscopic inspection revealed the guidewire exit port, and the distal section of the tip were in good condition.The functional test showed during a test guidewire was inserted, and no indication of resistance in tracking the guidewire into the catheter was noted.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 no problem detected 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 was found that could have contributed to the reported allegation.Also, the batch record review concluded that no manufacturing deviations were identified during the manufacturing process the manufacturing process that could have contributed to the complaint.

• 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: 24307287
• Report Number: 2124215-2026-07479
• Device Sequence Number: 15873021
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260205(10)35789348
• 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
• Report Date (Section B): 03/17/2026

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: 02/05/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0035789348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 88 KG