MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6 HD; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H74939354090
Medical Device Problem Codes	Unable to Obtain Readings (1516); Connection Problem (2900); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
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.Good faith effort attempts are being made to try and retrieve additional details regarding the reported event, but further information has not been obtained.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of unable to exclude device problem following a review of the reported event details, available information, and product record review.In this case the device was not returned for product analysis therefore limiting the identification of a most probable cause of the reported event, and batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.
Event or Problem Description
It was reported that catheter issue occurred.An opticross 6 hd catheter was selected for intravascular ultrasound (ivus) examination of the target lesion.During preparation, the device showed no image and air was not removed from the catheter during flushing.The procedure was completed using alternate device.No patient complications were reported.

• Brand Name: OPTICROSS? 6 HD
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 24634190
• Report Number: 2124215-2026-15011
• Device Sequence Number: 8596570
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• UDI-Public: (01)00191506035457(17)280122(10)38408212
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213593
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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 Model Number: H74939354090
• Device Catalogue Number: H74939354090
• Device Lot Number: 0038408212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 01/22/2026
• 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