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

Model Number	8668
Medical Device Problem Codes	Entrapment of Device (1212); Poor Quality Image (1408); Material Integrity Problem (2978); Material Twisted/Bent (2981); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the moderately tortuous and moderately calcified circumflex artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the catheter started spinning out of control and imaging was lost.The catheter almost separated into a knot and could not be pulled back.The catheter and guidewire were eventually removed as one unit.The guidewire was able to be separated from the catheter once outside the patient.The procedure was completed without ivus.There were no patient complications.

• Brand Name: OPTICROSS HD
• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20466131
• Report Number: 2124215-2024-64762
• Device Sequence Number: 12665688
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: 08714729960737
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 10/16/2024

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: 07/01/2025
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0034351907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/16/2024
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown