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

Model Number	39540
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole in the catheter occurred.The totally occluded target lesion was located in the non-tortuous and calcified superficial femoral artery.A 135cm rubicon 35 catheter was selected for use.During an attempt to get through the occlusion, it was noted that the distal end of the catheter folded onto itself, and the wire poked a hole through the catheter.The device was pulled and removed intact from the patients body.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of buckling/kinks located 135cm from the hub.There was a hole in the catheter shaft located 134.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a hole in the catheter occurred.The totally occluded target lesion was located in the non-tortuous and calcified superficial femoral artery.A 135cm rubicon 35 catheter was selected for use.During an attempt to get through the occlusion, it was noted that the distal end of the catheter folded onto itself, and the wire poked a hole through the catheter.The device was pulled and removed intact from the patients body.The procedure was completed with another of the same device.No 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
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15574359
• Report Number: 2124215-2022-40345
• Device Sequence Number: 2797508
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/03/2022

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: 07/18/2025
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0029794642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: 79 YR
• Patient Sex: Male
• Patient Race: Black Or African American