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

Model Number	H74939354090
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified ostial right coronary artery (rca).An opticross hd imaging catheter was selected for examination.During the procedure, the device had difficulty advancing and resistance was felt when removing the catheter, so the non-boston scientific (non-bsc) wire was also removed.Once out of the body, it was noticed that the tip was broke off at the distal marker band and remained on the non-bsc wire, with nothing left in the patient.The procedure was completed without performing imagining, and the patient fully recovered without complications.
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.
Event or Problem Description
It was reported that catheter issue occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified ostial right coronary artery (rca).An opticross hd imaging catheter was selected for examination.During the procedure, the device had difficulty advancing and resistance was felt when removing the catheter, so the non-boston scientific (non-bsc) wire was also removed.Once out of the body, it was noticed that the tip was broke off at the distal marker band and remained on the non-bsc wire, with nothing left in the patient.The procedure was completed without performing imagining, and the patient fully recovered without complications.
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.Investigation results: device analysis findings: returned product consisted of an opticross 6 hd.Visual inspection revealed no issues, and the device appeared to be in good condition.The tip was observed to be detached.Microscopic inspection showed that the guidewire exit port was lifted.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 adverse event related to procedure following a review of the returned device, reported event details, available information, and product record review.In this case, the lifted exit port occurs due to friction between the edges of the exit port and the guidewire, which could be found during advancement of the device into patient`s anatomy due to the lesion characteristics and the maneuvers of the user that could lead to excessive friction that deforms the material, and since no deviations were found in the dhr review, it is most probable that the issue occurred during the procedure.Regarding the tip detached, as no deviations in the manufacturing process were identified during the dhr review, it probably suffered significant forces due to the handling of the device during the procedure, which could have caused the detachment, and for this reason adverse event related to procedure is the assigned cause for this issue.

• 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: 24242018
• Report Number: 2124215-2026-05927
• Device Sequence Number: 18689143
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• UDI-Public: (01)00191506035457(17)271105(10)37882003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 0037882003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RUNTHROUGH WIRE; RUNTHROUGH WIRE
• Patient Sex: Unknown