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

Model Number	44021
Medical Device Problem Codes	Poor Quality Image (1408); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that catheter issue occurred.The target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.An opticross 18 was selected for use.During the procedure, the first intravascular ultrasound (ivus) was recorded.However, when user pullback and record second run, it was noted that there was no ivus image shown from the system during the second run, and the proximal shaft from the catheter was over-twisted.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that catheter issue occurred.The target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.An opticross 18 was selected for use.During the procedure, the first intravascular ultrasound (ivus) was recorded.However, when user pullback and record second run, it was noted that there was no ivus image shown from the system during the second run, and the proximal shaft from the catheter was over-twisted.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter address 1:(b)(6).Device evaluated by mfr: the device was returned for evaluation.The retainer hub returns with a fin outside the hub hole.A twist was observed in the imaging window assembly.In order to inspect for a damage in the imaging core at the proximal end of the catheter, the hub rotator retainer clip was removed.The rotator and imaging core assembly were pulled out from the removed hub.An ic windup began 155 cm from the distal end of the connector shaft.A kink and a twist were observed in the imaging window.An ic windup was observed in the core image.An impedance test was performed with the above referenced calibrated equipment.Impedance testing shows an electrical open at proximal wave form.No other issues were identified during the product analysis.

• 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: 21721764
• Report Number: 2124215-2025-15939
• Device Sequence Number: 9419020
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: (01)08714729904748(17)260504(10)33928578
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 05/04/2026
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0033928578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2024
• 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
• Patient Sex: Unknown