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

Model Number	39540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter separation occurred and was removed with a snare.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified iliac artery.A 90cm rubicon 35 guide catheter was selected for use.During the procedure, a catheter separation near the third marker from the tip was noted.The device fragment was removed with snaring device and the procedure was completed.No further patient injury was reported.
Event or Problem Description
It was reported that a catheter separation occurred and was removed with a snare.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified iliac artery.A 90cm rubicon 35 guide catheter was selected for use.During the procedure, a catheter separation near the third marker from the tip was noted.The device fragment was removed with snaring device and the procedure was completed.No further patient injury was reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of a kink located 17cm from the tip and a separation located 17.5cm from the tip.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The device was confirmed for a kink and a separation of the shaft.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17794543
• Report Number: 2124215-2023-47446
• Device Sequence Number: 5519014
• Product Code: DQY
• UDI-Device Identifier: 08714729832041
• UDI-Public: 08714729832041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 01/23/2026
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0030916650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: GUIDEWIRE:RADIFOCUS35; GUIDEWIRE:RADIFOCUS35; STENT:VBX; STENT:VBX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown