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

Model Number	H74939240035130
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Elderly female with 1-month history of gangrene of the left 4th and 5th toes.Attempted crossing of left superficial femoral artery (sfa) chronic total occlusion; v-14 wire inside a rubicon catheter inside the patient.The wire was stuck and as it was pulled back.Tip of the wire broke off being left behind in the patient.A second v-14 wire to continue to work on the patient¿s leg, this wire as well got stuck.The wire had to pulled out with the catheter to avoid another tip of a wire being left behind.After the wire was assessed it was determined that the tip had not completely detached.The rubicon catheter also had some fraying which may have caused the wires to fray."a v-14 wire was directed down the quick cross catheter.I exchanged the 035 quick cross catheter for an 014 rubicon catheter.Multiple attempts were made to cross into the true lumen where the vessel reach constituted.At 1 point the wire tip became stuck at the end of the rubicon catheter and sheared off in the distal left sfa chronic total occlusion.As there was no flow in this segment, i did not bother attempting to retrieve it.I attempted to use another 014 wire but could not cross into the true lumen.Once again, the distal tip of the wire became stuck at the end of the rubicon catheter.I then decided to pull both catheter and wire at the same time out through the sheath.The wire was frayed but intact".

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11494290
• Report Number: 11494290
• Device Sequence Number: 11748622
• Product Code: DQY
• UDI-Device Identifier: 08714729832126
• UDI-Public: (01)08714729832126(17)231211(10)26506874
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/12/2021
• Report Date (Section F): 03/12/2021

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 Model Number: H74939240035130
• Device Lot Number: 26506874
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1
• Patient Weight: 64
• Date Report Sent to FDA: 03/12/2021