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

Model Number	39540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rubicon broke into multiple pieces.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, the physician advanced a v18 guidewire to the chronic total occlusion sub-intimal.However, when the rubicon guide catheter was also pushed to the cto sub-intimal, it was noted that the guide catheter broke into multiple pieces.Consequently, the physician had to remove the remaining bits using a snare.The procedure was completed using a different device.No further patient complications were reported and patient's status post-procedure was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned device consisted of a rubicon 18 separated with 2 pieces returned.The 1st piece was 7.2cm long from the hub and showed a kink.The 2nd piece was 7cm long.No other components were returned.The device as designed is 90cm long.With approximately 14cm returned, the remainder of 76cm did not return.The 7cm long segment that was returned showed a broken guidewire inside the lumen and was buckled and kinked.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 rubicon broke into multiple pieces.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, the physician advanced a v18 guidewire to the chronic total occlusion sub-intimal.However, when the rubicon guide catheter was also pushed to the cto sub-intimal, it was noted that the guide catheter broke into multiple pieces.Consequently, the physician had to remove the remaining bits using a snare.The procedure was completed using a different device.No further patient complications were reported and patient's status post-procedure was stable.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8129696
• Report Number: 2134265-2018-63486
• Device Sequence Number: 10826002
• Product Code: DQY
• UDI-Device Identifier: 08714729829232
• UDI-Public: 08714729829232
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0022597000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V18 GUIDEWIRE; GUIDEWIRE: V18 GUIDEWIRE; GUIDEWIRE: V18 GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention