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

Model Number	44021
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became entangled with the guidewire.The opticross 18 catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the device was advanced through a 0.018 wire to the transseptal puncture (tp) trunk.However, when attempting a pullback, the images were unstable and showed excessive distortion artifacts, and during attempts to withdraw the device, the catheter became entangled with the guidewire.Upon removal from the patient, the catheter was observed to be kinked.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the device became entangled with the guidewire.The opticross 18 catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the device was advanced through a 0.018 wire to the transseptal puncture (tp) trunk.However, when attempting a pullback, the images were unstable and showed excessive distortion artifacts, and during attempts to withdraw the device, the catheter became entangled with the guidewire.Upon removal from the patient, the catheter was observed to be kinked.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that kinks were observed in the imaging window assembly.Also, visual inspection noted there was no return of a guidewire entangled with the device.The allegation of guidewire entanglement could not be confirmed since no damages were found during the visual testing.The allegation of catheter kink was confirmed since kinks were observed during testing.
Additional Manufacturer Narrative
B5: describe event or problem: corrected.The device was returned for analysis.Visual inspection revealed that kinks were observed in the imaging window assembly.Also, visual inspection noted there was no return of a guidewire entangled with the device.The allegation of guidewire entanglement could not be confirmed since no damages were found during the visual testing.The allegation of catheter kink was confirmed since kinks were observed during testing.
Event or Problem Description
It was reported that the device became entangled with the guidewire.It was reported to boston scientific (bsc) that the referenced opticross 18 peripheral imaging catheter was selected for an intravascular ultrasound (ivus) procedure on 11july 2024.The lesion was located in the left superficial artery to popliteal artery.During the procedure, the opticross 18 peripheral imaging catheter was advanced over a 0.018 inch guidewire to the tibioperoneal trunk.However, when attempting a pullback, the images were unstable and showed excessive distortion artifacts, and, the catheter became entangled with the guidewire during withdrawal attempts.Upon removal of the opticross 18 catheter from the patient, the catheter was observed to be kinked.The procedure was completed with another of the same device and no patient complications were reported as a result of the event.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19921917
• Report Number: 2124215-2024-45434
• Device Sequence Number: 8188683
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: 08714729904748
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 12/19/2025
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0033092362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 01/08/2025
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/30/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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