MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross; catheter, ultrasound, intravascular

Model Number	H749518100
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.An opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the catheter was advanced over the guidewire to the distal segment for ivus examination.The patients vessels were extremely tortuous and stenotic, with multiple segments exhibiting angulations greater than 60 degrees.Automatic pullback of the ivus catheter was not possible, and catheter entrapment with a potential tip fracture was suspected.Attempts to retrieve the catheter by the operator were unsuccessful.The fractured catheter tip remained in the patient, and multiple stents were deployed to completely cover the lesion and secure the fractured tip against the vessel wall.Post dilation was performed repeatedly using a non-compliant balloon to ensure adequate stent apposition.Intensified antiplatelet therapy was administered after the procedure.The procedure was completed with another of the same device.The patient was stable following the procedure.There were no patient complications.
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.An opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the catheter was advanced over the guidewire to the distal segment for ivus examination.The patients vessels were extremely tortuous and stenotic, with multiple segments exhibiting angulations greater than 60 degrees.Automatic pullback of the ivus catheter was not possible, and catheter entrapment with a potential tip fracture was suspected.Attempts to retrieve the catheter by the operator were unsuccessful.The fractured catheter tip remained in the patient, and multiple stents were deployed to completely cover the lesion and secure the fractured tip against the vessel wall.Post dilation was performed repeatedly using a non-compliant balloon to ensure adequate stent apposition.Intensified antiplatelet therapy was administered after the procedure.The procedure was completed with another of the same device.The patient was stable following the procedure.There were no patient complications.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6) 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: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to patient condition.It is most likely the presence of reported anatomical factors, presented a constriction over the device and increase the friction when the device was advancing through the lesion reducing the mobility and generating the reported issue.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).

• 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 ; +1(612)875-7234
• MDR Report Key: 50116239
• Report Number: 2124215-2026-41454
• Device Sequence Number: 10039955
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)270319(10)38881901
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0038881901
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 03/19/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 167 LB