MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH

Model Number	29420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the catheter was broken.A renegade hi-flo catheter was selected for use in an embolization procedure.While opening the device package and removing the device, the catheter broke.Another renegade hi-flo catheter was selected for use.The procedure was completed.There were no patient consequences.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device eval by mfr: the device was returned and analysis completed.The device returned partially in the shipping hoop.The shipping hoop was hydrated, and the device was removed.The device was inspected for any damage or irregularities.The device showed 2 fractures located 2.2cm and 10.4cm from the hub.The device was not completely separated as the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for fractures.
Event or Problem Description
It was reported that the catheter was broken.A renegade hi-flo catheter was selected for use in an embolization procedure.While opening the device package and removing the device, the catheter broke.Another renegade hi-flo catheter was selected for use.The procedure was completed.There were no patient consequences.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter last name: updated.E3 - occupation: updated to physician.
Event or Problem Description
It was reported that the catheter was broken.A renegade hi-flo catheter was selected for use in an embolization procedure.While opening the device package and removing the device, the catheter broke.Another renegade hi-flo catheter was selected for use.The procedure was completed.There were no patient consequences.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17819858
• Report Number: 2124215-2023-50842
• Device Sequence Number: 6100975
• Product Code: KRA
• UDI-Device Identifier: 08714729280668
• UDI-Public: 08714729280668
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140329
• 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,Followup
• Report Date (Section B): 11/09/2023

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: 12/03/2025
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0030775883
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 09/27/2023; 10/19/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/18/2023; 11/09/2023
• 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
• Patient Sex: Unknown