MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 14; 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	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 - lot number: 34994378 was reported but could not be verified.E1 - initial reporter phone: (b)(6).Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that device entrapment occurred.A rubicon 14 support catheter was selected for use in a percutaneous transluminal angioplasty procedure to treat vascular stenosis.During the procedure, the wire became stuck in the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D4 - lot number: 34994378 was reported but could not be verified.(b)(6).Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.Device evaluated by mfr: the rubicon 14 device was returned to our post market quality assurance laboratory.The returned device consisted of a rubicon 14 with dried blood in the shaft.The device was soaked in the ultrasonic bath for over 24 hours with a pressure syringe attached in an attempt to flush the device.The device failed the wire insertion test, as the shaft was occluded with dried blood.The device could not be flushed.
Event or Problem Description
It was reported that device entrapment occurred.A rubicon 14 support catheter was selected for use in a percutaneous transluminal angioplasty procedure to treat vascular stenosis.During the procedure, the wire became stuck in the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: RUBICON 14
• 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: 23693232
• Report Number: 2124215-2025-85588
• Device Sequence Number: 13032290
• Product Code: DQY
• UDI-Device Identifier: 08714729799085
• UDI-Public: (01)08714729799085
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112303
• 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): 01/15/2026

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
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 82 YR
• Patient Sex: Female