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

Model Number	39540
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Inspection of the device revealed damage and a perforation to the encapsulation sleeve along with dried blood through the catheter.An.014 test guidewire was used and was unable to pass the dried blood throughout the catheter.The reported allegation was confirmed due to shaft damage and guidewire advancement issues due to the presence of blood.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that the shaft was damaged.The target lesion was located in the severely calcified superficial femoral artery (sfa) vessel below the knee (btk).A 135cm rubicon 18 catheter-guide selected for sfa btk percutaneous transluminal angioplasty case and loaded onto the non-boston scientific wire to pass the lesion.However, the rubicon catheter was removed from the patient's body as it became stuck while following the wire.It was found to be bumpy in the middle part of the catheter.The physician complained and completed the procedure with another of the same product.No complications were reported, and the patient was fine.However, device analysis revealed damaged and perforation to the shaft.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19378366
• Report Number: 2124215-2024-30407
• Device Sequence Number: 7618831
• Product Code: DQY
• UDI-Device Identifier: 08714729829249
• UDI-Public: 08714729829249
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/22/2024

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: 01/02/2026
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0030782819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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: ABBOTT COMMAND
• Patient Age: 67 YR
• Patient Sex: Male