MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 18; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06 jun 2023.It was reported, that the guidewire was stuck.The 90% stenosed target lesion was located in the severely tortuous, and severely calcified superficial femoral artery.A 135cm rubicon 18 catheter-guide was selected for use.During the procedure, the device could not cross the lesion.And the guidewire got stuck in the rubicon.The procedure was completed with another of the same device.No complications were reported.However, device analysis revealed, the tip was separated and missing.
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 stretching and a tip detachment.The device was measured and should be 135cm as designed.The device measured 135.2cm from the hub with the damage.The device showed, that it was stretched.And the tip was separated and missing.A.018 test guidewire was used to insert into the device.When the wire reached the stretched area of the device, it would not transcend any further.Inspection of the remainder of the device, apart from the observed damage revealed, no other damage or irregularities.

• Brand Name: RUBICON 18
• 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: 17204204
• Report Number: 2124215-2023-29619
• Device Sequence Number: 12429040
• Product Code: DQY
• UDI-Device Identifier: 08714729829249
• UDI-Public: 08714729829249
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: 08/03/2025
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0029891839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male