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

Model Number	39540
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter fractured.The target lesion was located in the superficial femoral artery (sfa).A 135cm rubicon 18 guide catheter was selected for use.The rubicon guide catheter was advanced approximately 10 cm over a guidewire, and then it became stuck.The proximal shaft was noted to be kinked.A shaft fracture was observed outside of the patient, approximately 40cm from the proximal hub.The catheter was removed still intact.The procedure was completed with another of same device.There were no patient complications.
Event or Problem Description
It was reported that the catheter fractured.The target lesion was located in the superficial femoral artery (sfa).A 135cm rubicon 18 guide catheter was selected for use.The rubicon guide catheter was advanced approximately 10 cm over a guidewire, and then it became stuck.The proximal shaft was noted to be kinked.A shaft fracture was observed approximately 40cm proximal from the hub.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by mfr: the rubicon 18 guide catheter was returned and analysis was completed.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of a kink located 112.5cm from the tip.A.016 test guidewire was inserted into the catheter lumen and the wire transcended through the device until it reached the kink where a restriction was felt; however, the wire did pass through the device.There was no fracture of the device.Inspection of the remainder of the device revealed no other damage or irregularities.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13446374
• Report Number: 2134265-2022-01120
• Device Sequence Number: 4321674
• Product Code: DQY
• UDI-Device Identifier: 08714729829249
• UDI-Public: 08714729829249
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 09/28/2024
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0028109967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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