MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800350
Medical Device Problem Codes	Poor Quality Image (1408); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b product code (pro code): itx.
Event or Problem Description
It was reported that a catheter issue occurred.The patient presented with 60% iliac vein stenosis.The oc35 imaging catheter was advanced for ultrasound examination of the non-calcified and non-tortuous target lesion.As the catheter was being moved to position for imaging the vessel, the telescope hub and telescope catheter became disconnected and at the same time, a halo was noticed around the image on the screen.The device was removed, and the procedure completed using an alternate device.There were no patient complications.
Additional Manufacturer Narrative
D2b product code (pro code): itx.The device was returned for analysis.Visual inspection revealed the anchor housing was detached.Impedance testing showed an electrical open between 70-80 cm distal from the distal housing.Inspection of media provided by the customer showed the anchor housing was detached and the telescope kinked.
Event or Problem Description
It was reported that a catheter issue occurred.The patient presented with 60% iliac vein stenosis.The oc35 imaging catheter was advanced for ultrasound examination of the non-calcified and non-tortuous target lesion.As the catheter was being moved to position for imaging the vessel, the telescope hub and telescope catheter became disconnected and at the same time, a halo was noticed around the image on the screen.The device was removed, and the procedure completed using an alternate device.There were no patient complications.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18557817
• Report Number: 2124215-2024-03131
• Device Sequence Number: 6383412
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• 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,Followup
• Report Date (Section B): 03/25/2024

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: 10/05/2025
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0032911817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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