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

Model Number	H7493932800350
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): obj, itx.
Event or Problem Description
It was reported that catheter perforation occurred.The patient presented for a bilateral venous case.The opticross 35 imaging catheter was advanced over an amplatz ss guidewire for ultrasound examination of the target lesion.The stiff end of the amplatz exited through the side of the opticross creating a hole in the catheter.The procedure was completed successfully with another opticross 35 catheter.There were no patient complications.
Additional Manufacturer Narrative
D2b pro code (product code): obj, itx.The device was returned for analysis.Visual inspection revealed no issues with the device with it appearing to be in good condition.Microscopic and functional inspection revealed a perforation in the guidewire lumen.
Event or Problem Description
It was reported that catheter perforation occurred.The patient presented for a bilateral venous case.The opticross 35 imaging catheter was advanced over an amplatz ss guidewire for ultrasound examination of the target lesion.The stiff end of the amplatz exited through the side of the opticross creating a hole in the catheter.The procedure was completed successfully with another opticross 35 catheter.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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16734471
• Report Number: 2124215-2023-17464
• Device Sequence Number: 15102587
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 10/18/2024
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0030503512
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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: Female