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

Model Number	39540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: late 60s.
Event or Problem Description
It was reported that the catheter broke into two pieces and was retrieved by snare.The greater than 90% stenosed target lesion was located in the very tortuous and heavily calcified external iliac artery.A 90cm rubicon 35 catheter was selected for use.During procedure, it was noted that the catheter broke into two pieces.The physician never lost wire access from the vessel or catheter tip.The device was retrieved using a 6fr 45 cm sheath by cinching the snare loops to the broken rubicon tip and the procedure was completed with a different device.No further patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: late 60s.Device evaluated by mfr: the device was returned for evaluation.Analysis of the stent, tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed a shaft separation located 16.1cm from the tip.The separated ends (material) were observed to have been stretched and twisted/torqued.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that the catheter broke into two pieces and was retrieved by snare.The greater than 90% stenosed target lesion was located in the very tortuous and heavily calcified external iliac artery.A 90cm rubicon 35 catheter was selected for use.During procedure, it was noted that the catheter broke into two pieces.The physician never lost wire access from the vessel or catheter tip.The device was retrieved using a 6fr 45 cm sheath by cinching the snare loops to the broken rubicon tip and the procedure was completed with a different device.No further patient complications were reported.

• 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: 10707112
• Report Number: 2134265-2020-14425
• Device Sequence Number: 3345608
• Product Code: DQY
• UDI-Device Identifier: 08714729832041
• UDI-Public: 08714729832041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122394
• 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): 11/10/2020

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: 06/13/2023
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0025594511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: Required Intervention