MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8655
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.The target lesion was located in the right coronary artery.An opticross 6 catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.When the catheter was being pulled back after the ivus run was completed, the guidewire was stuck in the lumen.The entire guidewire was pulled from the vessel and became damaged.The tip of the catheter was also noted to be damaged.The procedure was successfully completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed no issues and the device appeared to be in good condition.Microscopic inspection revealed the guidewire exit port and tip were in good condition.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.
Event or Problem Description
It was reported that catheter issue occurred.The target lesion was located in the right coronary artery.An opticross 6 catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.When the catheter was being pulled back after the ivus run was completed, the guidewire was stuck in the lumen.The entire guidewire was pulled from the vessel and became damaged.The tip of the catheter was also noted to be damaged.The procedure was successfully completed with a different device.No patient complications were reported.It was further reported that the guidewire was non-boston scientific.

• Brand Name: OPTICROSS 6
• 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: 17861763
• Report Number: 2124215-2023-53691
• Device Sequence Number: 14885509
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 05/10/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0031595642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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