MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 18; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility: (b)(6), initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in an artery of lower extremity.A 150cm rubicon catheter-guide was selected for use.During the procedure, the catheter and the guide wire were entangled with each other.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in an artery of lower extremity.A 150cm rubicon catheter-guide was selected for use.During the procedure, the catheter and the guide wire were entangled with each other.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: (b)(6).With the available information, boston scientific concludes: device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis: the rubicon guide catheter was returned for evaluation.The device was visually examined to reveal no damage.A wire insertion test was performed successfully by inserting a.016" guidewire.No other issues were identified during the product analysis.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review was completed and confirmed that the event of entrapment of device was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as device problem exclude because the inspection of the returned device revealed no damage or irregularities.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24191355
• Report Number: 2124215-2026-04722
• Device Sequence Number: 9851361
• Product Code: DQY
• UDI-Device Identifier: 08714729829256
• UDI-Public: (01)08714729829256(17)270403(10)33754306
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122394
• 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): 03/12/2026

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 Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0033754306
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 89 KG