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

Model Number	39540
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter perforation occurred.A 260cm zipwire and 035 inches x 135cm rubicon were selected for use.During the procedure, the physician was trying to cross a very calcified aortic bifurcation using 035 inches x 135cm rubicon and a zipwire 260cm.The rubicon was kinked and upon removing the catheter it was slightly bent.Additionally, when the tech flush the rubicon it was noted that there were holes in the side of the catheter and when the zipwire was removed the coating on the tip of the wire had sheared off.The physician continued with the case and was able to cross the aortic bifurcation and successfully performed atherectomy using a 2.5 rotablator on the lesions.Furthermore, it was noted after a post treatment angiogram that there was something in the mid superficial femoral artery (sfa).It was presumed to be the coating tip of the zipwire, so the physician deployed a 6mm x 40mm eluvia stent to ensure the object did not travel and possibly embolize the distal artery.The post angiogram pictures confirmed brisk flow throughout the rle.The device was simply removed, and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of multiple bends/kinks located 122cm from the hub to the tip.There was a hole in the catheter shaft located 124.5cm 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 a device fracture occurred.A 260cm and 035 x 135cm rubicon zipwire were selected for use.During the procedure, the physician was trying to cross a very calcified aortic bifurcation using an 035 x 135cm rubicon and a zipwire 260cm.The rubicon was kinked and upon removing the catheter it was slightly bent.Additionally, when the tech flush the rubicon it was noted that there were holes in the side of the catheter and when the zipwire was removed the coating on the tip of the wire had sheared off.The physician continued with the case and was able to cross the aortic bifurcation and successfully performed atherectomy using a 2.5 rotablator on the lesions.Furthermore, it was noted after a post treatment angiogram that there was something in the mid superficial femoral artery (sfa).It was presumed to be the coating tip of the zipwire so the physician deployed a 6mm x 40mm eluvia stent to ensure the object did not travel and possibly embolize the distal artery.The post angiogram pictures confirmed brisk flow throughout the rle.The procedure was completed with a non-bsc device.There were no patient complications reported.

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16812108
• Report Number: 2124215-2023-16972
• Device Sequence Number: 5682890
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 01/05/2026
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0030805865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5FR BERN CATHETER - CATHETER; 5FR BERN CATHETER - CATHETER; AMPLATZ WIRE - GUIDEWIRE; AMPLATZ WIRE - GUIDEWIRE; ROSEN - GUIDEWIRE; ROSEN - GUIDEWIRE
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White