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

Model Number	39540
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter break occurred and detached piece was removed through snaring.The more than 80% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of the left lower extremity.A 150cm rubicon 18 catheter guide was selected for use in a left leg extremity arteriogram.During the procedure, the rubicon was advanced past the guidewire and resistance was met.Upon pulling back, the catheter was kinked.Rubicon catheter was tugged, and it was noted that the catheter detached at the second radiopaque (ro) marker.The remainder of the catheter was removed, and the detached piece was successfully retrieved using a non-boston scientific (bsc) snare kit.The procedure was completed with another of the same device without further issues.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was examined visually, and it was found that the tip section of the device was detached at approximately 154cm from the hub.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that catheter break occurred and detached piece was removed through snaring.The more than 80% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of the left lower extremity.A 150cm rubicon 18 catheter guide was selected for use in a left leg extremity arteriogram.During the procedure, the rubicon was advanced past the guidewire and resistance was met.Upon pulling back, the catheter was kinked.Rubicon catheter was tugged, and it was noted that the catheter detached at the second radiopaque (ro) marker.The remainder of the catheter was removed, and the detached piece was successfully retrieved using a non-boston scientific (bsc) snare kit.The procedure was completed with another of the same device without further issues.No patient complications were reported.

• 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: 19130526
• Report Number: 2124215-2024-19828
• Device Sequence Number: 14617143
• Product Code: DQY
• UDI-Device Identifier: 08714729829256
• UDI-Public: 08714729829256
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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 Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0033516317
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: Black Or African American