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	11/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.A rubicon 18, 135cm catheter and a v-18 control wire were used for lower limb stent implantation.During the procedure, the guide wire and the rubicon support catheter became stuck and could not be separated.Both devices were pulled out and the procedure was completed with another of the same device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
B5: updated event description with additional information.Upon receipt at our post market quality assurance laboratory, the device was examined with multiple methods.Visually, the guidewire was stuck in the rubicon.The guidewire was measured with the led micrometer and has the correct specifications for the device.By using a tuohy borst to flush the microcatheter, the device failed to flush water.The device was soaked in the ultrasonic bath for over 24 hours and failed to remove the guidewire from the microcatheter.The device was viewed in the x-ray to reveal occlusion approximately 3.5cm from the distal tip.The reported event of entrapment of device was confirmed.
Event or Problem Description
It was reported that device entrapment occurred.A rubicon 18, 135cm catheter and a v-18 control wire were used for lower limb stent implantation.During the procedure, the guide wire and the rubicon support catheter became stuck and could not be separated.Both devices were pulled out and the procedure was completed with another of the same device.The patient condition following procedure was stable.It was further reported that the target lesion was 70% stenosed and was located in the moderately tortuous and severely calcified vessel.

• 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: 21212292
• Report Number: 2124215-2025-02390
• Device Sequence Number: 12780388
• Product Code: DQY
• UDI-Device Identifier: 08714729829249
• UDI-Public: 08714729829249
• 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): 03/07/2025

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 Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0034051264
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG