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

Model Number	8655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 impact code insufficient information - the device was returned with no allegation.The device was returned for analysis.Visual inspection revealed the tip of the catheter was stuck on the floppy end of the guide wire.The rotator and imaging core assembly could not be removed from the hub due to the condition of the device so imaging core windup was not inspected.The catheter was properly recognized by the imaging system when plugged into the motor drive unit and no connection issues or errors were detected during testing.Impedance testing shows an electrical open at the proximal wave form.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray images, the electrical failure was found to be a result of a broken coax cable at 130cm to 140cm.
Event or Problem Description
Reportable based on device analysis completed on 20apr2023.The opticross imaging catheter was returned without any allegation of a device issue.However, device analysis revealed entrapment.

• Brand Name: OPTICROSS
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16891358
• Report Number: 2124215-2023-22388
• Device Sequence Number: 14975284
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: 01/09/2024
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0030817883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown