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

Model Number	8655
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscopic inspection revealed the sheath assembly was kinked and the imaging window was observed twisted.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that imaging window failure to rotate occurred.The opti cross imaging catheter was selected for ultrasound examination of the target lesion.After the catheter was prepared, the motor drive unit was started but the intravascular ultrasound drive shaft did not spin.A few reconnections were done but the device still did not spin.The procedure was completed successfully.There were no patient complications reported.However, device analysis revealed the imaging window was twisted.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that imaging window failure to rotate occurred.The opti cross imaging catheter was selected for ultrasound examination of the target lesion.After the catheter was prepared, the motor drive unit was started but the intravascular ultrasound drive shaft did not spin.A few reconnections were done but the device still did not spin.The procedure was completed successfully.There were no patient complications reported.However, device analysis revealed the imaging window was twisted.The device was returned for analysis.Visual and microscopic inspection revealed the sheath assembly was kinked and the imaging window was observed twisted.
Additional Manufacturer Narrative
Update to device analysis by mfr: the device was reopened for analysis.Visual inspection revealed tip assembly was kinked.The motor drive unit (mdu) and the ilab system were used to perform a functional inspection on the device.The catheter was plugged into the mdu, and no issues or errors were detected during rotation test.Regarding the encountered kink in the sheath and tip, a kink can occur outside the patient due to forces related to the handling of the device.If the user applies a bending force over the sheath and tip, it could bend and consequently collapse into the kinks observed, this could occur during the unpacking or preparation when the device is being held.

• 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: 18411521
• Report Number: 2124215-2023-73604
• Device Sequence Number: 2932943
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/09/2024

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: 06/14/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0031803839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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