MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke.The target lesion was located in right femoral artery.A 150cm rubicon 35 was selected for use.During the procedure, the device was advanced over the iliac bifurcation to the patient's left side.Subsequently, the catheter was found to be kinked.The device was removed from the patient and found out that the device was fractured completely through on one side.There were no fragments of the device that was left inside the patient.The procedure was completed with another of same device.No patient complications reported and patient is doing well.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned device consisted of a rubicon 35.The device showed multiple kinks on the distal end of the shaft.The shaft showed a fracture located 14.8cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the device broke.The target lesion was located in right femoral artery.A 150cm rubicon 35 was selected for use.During the procedure, the device was advanced over the iliac bifurcation to the patient's left side.Subsequently, the catheter was found to be kinked.The device was removed from the patient and found out that the device was fractured completely through on one side.There were no fragments of the device that was left inside the patient.The procedure was completed with another of same device.No patient complications reported and patient is doing well.

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8288823
• Report Number: 2134265-2019-00563
• Device Sequence Number: 16679505
• Product Code: DQY
• UDI-Device Identifier: 08714729832058
• UDI-Public: 08714729832058
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 11/05/2021
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0022900274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1