MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6; 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	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that entrapment occurred.The opticross 6 was introduced for visualization of the target lesion.After imaging was completed, the physician tried to remove the catheter but it snagged the guidewire and both devices were removed together.There was no harm to the patient.
Additional Manufacturer Narrative
The device was returned for analysis.A kink was observed in the male telescope assembly.No other visual damages were encountered upon visual inspection.Microscopic inspection revealed the guidewire exit port was torn.
Event or Problem Description
It was reported that entrapment occurred.The opticross 6 was introduced for visualization of the target lesion.After imaging was completed, the physician tried to remove the catheter but it snagged the guidewire and both devices were removed together.There was no harm to the patient.

• Brand Name: OPTICROSS 6
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11456963
• Report Number: 2134265-2021-03147
• Device Sequence Number: 11539674
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 11/24/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0026416700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/09/2021
• Patient Sequence Number: 1