MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross 35; catheter, ultrasound, intravascular

Model Number	H7493932800350
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the right iliac vein.The opticross 35 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, after removing the ivus catheter from the left iliac vein and advancing it over to the right iliac vein, it was removed from the right and positioned up the left wire to reference the left confluence.The opticross catheter became stuck on the wire.The wire and opticross catheter were removed together and replaced, and the procedure was completed successfully.No patient injury was reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that the guidewire was stuck in the catheter.A functional test on a test guidewire could not be performed since a non-boston scientific guidewire was returned.However, this guidewire was stuck inside the device.
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the right iliac vein.The opticross 35 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, after removing the ivus catheter from the left iliac vein and advancing it over to the right iliac vein, it was removed from the right and positioned up the left wire to reference the left confluence.The opticross catheter became stuck on the wire.The wire and opticross catheter were removed together and replaced, and the procedure was completed successfully.No patient injury was reported.

• Brand Name: OptiCross 35
• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 19682956
• Report Number: 2124215-2024-39492
• Device Sequence Number: 3115984
• Product Code: OBJ
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2026

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: 02/21/2026
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0034068240
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/27/2024; Not provided
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/23/2024; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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