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

Model Number	8655
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 70% stenosed target lesion was located in the moderately calcified and mildly tortuous renal artery.The opticross us imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the catheter stuck to the guidewire and caused it to kink near the tip, exit port.The device remained intact but had to be removed together with the guidewire.The procedure was completed with another catheter.There were no patient complications.

• Brand Name: OPTICROSS
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12774693
• Report Number: 2134265-2021-14024
• Device Sequence Number: 5271262
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• 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
• Report Date (Section B): 11/08/2021

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: 05/29/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0027405050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female