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

Model Number	39540
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch (b)(4) that the procedure was cancelled.The chronic totally occluded target lesion was located in the superficial femoral artery (sfa).Two 300cm straight tip v-14 control wire guidewires and a 135cm rubicon 35 guide catheter were selected for use.During the procedure, it was noted that the tip of the first guidewire became stuck at the end of the rubicon catheter and sheared off in the distal left sfa.The detached fragment remained in the patient's body.The physician did not attempt to retrieve the wire tip as there was no flow in this segment.Subsequently, the second guidewire was used but could not cross into the true lumen and the distal tip of the wire also became stuck at the end of the rubicon catheter.The physician pulled out both catheter and wire at the same time through the sheath.The wire was frayed but intact.The physician removed everything from the sfa and aborted the procedure.No complications were reported and the patient was fine post procedure.
Event or Problem Description
It was reported via medwatch (b)(4) that the procedure was cancelled.The chronic totally occluded target lesion was located in the superficial femoral artery (sfa).Two 300cm straight tip v-14 control wire guidewires and a 135cm rubicon 35 guide catheter were selected for use.During the procedure, it was noted that the tip of the first guidewire became stuck at the end of the rubicon catheter and sheared off in the distal left sfa.The detached fragment remained in the patient's body.The physician did not attempt to retrieve the wire tip as there was no flow in this segment.Subsequently, the second guidewire was used but could not cross into the true lumen and the distal tip of the wire also became stuck at the end of the rubicon catheter.The physician pulled out both catheter and wire at the same time through the sheath.The wire was frayed but intact.The physician removed everything from the sfa and aborted the procedure.No complications were reported and the patient was fine post procedure.It was further reported that the rubicon catheter also frayed which may have caused the wires to fray.
Event or Problem Description
It was reported via medwatch 3600840000-2021-8035 that the procedure was cancelled.The chronic totally occluded target lesion was located in the superficial femoral artery (sfa).Two 300cm straight tip v-14 control wire guidewires and a 135cm rubicon 35 guide catheter were selected for use.During the procedure, it was noted that the tip of the first guidewire became stuck at the end of the rubicon catheter and sheared off in the distal left sfa.The detached fragment remained in the patient's body.The physician did not attempt to retrieve the wire tip as there was no flow in this segment.Subsequently, the second guidewire was used but could not cross into the true lumen and the distal tip of the wire also became stuck at the end of the rubicon catheter.The physician pulled out both catheter and wire at the same time through the sheath.The wire was frayed but intact.The physician removed everything from the sfa and aborted the procedure.No complications were reported and the patient was fine post procedure.It was further reported that the rubicon catheter also frayed which may have caused the wires to fray.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a rubicon guide catheter and the related guidewire.There was dried blood throughout the shaft of the rubicon.The device was soaked for 4 days, but the wire could not be removed/separated from the rubicon.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed tip damage (stretched down over wire), the shaft was damaged (stretched down over wire) starting at the tip and continued for approximately 41cm.The shaft damage was observed to be tight over the wire, preventing the wire from moving within the device.Inspection of the rest of the device found no other damage or defects.

• 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: 11597030
• Report Number: 2134265-2021-04064
• Device Sequence Number: 11636685
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2021

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: 12/11/2023
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0026506874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 04/21/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/02/2021; 05/10/2021
• 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: V-14 CONTROL WIRE; GUIDEWIRE: V-14 CONTROL WIRE; GUIDEWIRE: V-14 CONTROL WIRE
• Patient Age: 66 YR
• Patient Weight: 64