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	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with may-thurner syndrome for a venogram.The target lesion was located in a non-tortuous and non-calcified iliac vein.The oc35 imaging catheter was advanced for ultrasound examination of the target lesion.When the device was being removed over a non-boston scientific guidewire, the device became stuck on the wire and the devices had to be removed together through the sheath.The procedure was completed using an alternate device.There were no patient complications.
Additional Manufacturer Narrative
Pro code (product code): obj, itx.
Additional Manufacturer Narrative
D2b pro code (product code): obj, itx.The device was returned for analysis.Visual inspection revealed the device was returned with a guide wire stuck due residues in the guide wire lumen and with sections of the guide wire lumen torn.Microscopic inspection revealed the transducer housing near the distal tip, also guide wire lumen torn was observed.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with may-thurner syndrome for a venogram.The target lesion was located in a non-tortuous and non-calcified iliac vein.The oc35 imaging catheter was advanced for ultrasound examination of the target lesion.When the device was being removed over a non-boston scientific guidewire, the device became stuck on the wire and the devices had to be removed together through the sheath.The procedure was 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15686456
• Report Number: 2124215-2022-44084
• Device Sequence Number: 17976285
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/20/2022

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: 10/25/2022
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0028610965
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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 Age: 73 YR
• Patient Sex: Female