MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 14; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via user facility report # mw5079859 that the wire tip broke and remained inside patient's body.A rubicon 14 was selected for use.During procedure, while trying to cross the chronically occluded tibial vessel, it was noticed that 3mm of the tip of wire broke off in the heavily calcified portion of the occlusion.Furthermore, the detached portion did not affect arterial flow or change the patient's condition and was left in place.No further patient complications were reported.
Event or Problem Description
It was reported via user facility report # mw5079859 that the wire tip broke and remained inside patient's body.A rubicon 14 was selected for use.During procedure, while trying to cross the chronically occluded tibial vessel, it was noticed that 3mm of the tip of wire broke off in the heavily calcified portion of the occlusion.Furthermore, the detached portion did not affect arterial flow or change the patient's condition and was left in place.No further patient complications were reported.It was further reported that no other devices were used to complete the procedure.No additional interventions were done to remove the device from the patient; the detached portion was not removed from the patient.No patient complications occurred.The patient's status post-procedure was stable.

• Brand Name: RUBICON 14
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8010659
• Report Number: 2134265-2018-62345
• Device Sequence Number: 1746940
• Product Code: DQY
• UDI-Device Identifier: 08714729799085
• UDI-Public: 08714729799085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112303
• 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): 11/02/2018

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: 12/27/2020
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0021550838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other