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

Model Number	H749518100
Medical Device Problem Codes	Nonstandard Device (1420); Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The 70% stenosed target lesion was located in the severely tortuous and severely calcified distal left anterior descending artery.The opticross hd imaging catheter was selected for intravascular ultrasound examination.During the procedure, the catheter could not be connected due to its damaged tip.The procedure was not completed due to this event.The patient remained stable, and no complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Visual inspection revealed that the retainer clip was missing, and the hub rotator, along with the shorting plug, was out of the hub.No damage or failures were observed on the catheter code pcba (ccp) board assembly or on the hub connector pins.Microscope inspection showed that the guidewire exit port and the distal section of the tip were in good condition.Functional testing showed that the catheter was properly recognized by the imaging system when connected to the mdu, and no connection issues or errors were detected during testing.No resistance was noted when 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 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 that could have contributed to the reported allegation.
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The 70% stenosed target lesion was located in the severely tortuous and severely calcified distal left anterior descending artery.The opticross hd imaging catheter was selected for intravascular ultrasound examination.During the procedure, the catheter could not be connected due to a damaged tip.The procedure was not completed due to this event.The patient remained stable, and no complications were reported.

• 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: 23771640
• Report Number: 2124215-2025-90219
• Device Sequence Number: 18555961
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260703(10)36890702
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/08/2026

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: 07/03/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0036890702
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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