MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	44021
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter broke inside the patient, requiring additional devices for removal.The target lesion was located in the mildly tortuous and mildly calcified vessel.An opticross 18 imaging catheter was selected for peripheral procedure.However, during the procedure, it was noted that the catheter drive shaft became twisted and then snapped, leaving a part of the catheter inside the patient.The physician attempted to remove the broken device using different techniques, including alligator clips and a snare, but was unsuccessful.On (b)(6) 2024, the small piece of device that broke off was removed from patient's body.The patient is good post-procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that the catheter broke inside the patient, requiring additional devices for removal.The target lesion was located in the mildly tortuous and mildly calcified vessel.An opticross 18 imaging catheter was selected for peripheral procedure.However, during the procedure, it was noted that the catheter drive shaft became twisted and then snapped, leaving a part of the catheter inside the patient.The physician attempted to remove the broken device using different techniques, including alligator clips and a snare, but was unsuccessful.On (b)(6) 2024, the small piece of device that broke off was removed from patient's body.The patient is good post-procedure.It was further reported that the device was removed through minimal invasive type.

• Brand Name: OPTICROSS 18
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20474557
• Report Number: 2124215-2024-63916
• Device Sequence Number: 7629790
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: 08714729904748
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160514
• 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): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 44021
• Device Catalogue Number: 44021
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown