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

Model Number	29460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported that microcatheter was fractured.The target lesion was located in the liver.The blood vessels of the anatomical structure have more small curves, and the blood vessels of the abdominal trunk and common hepatic artery are "u" shape.A 135/10 renegade hi flo kit was selected for use.During the procedure, it was found that the tip got fractured at the proximal end, the connection between the hub and the microcatheter and could not be used any longer.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that microcatheter was fractured.The target lesion was located in the liver.The blood vessels of the anatomical structure have more small curves, and the blood vessels of the abdominal trunk and common hepatic artery are "u" shape.A 135/10 renegade hi flo kit was selected for use.During the procedure, it was found that the tip got fractured at the proximal end, the connection between the hub and the microcatheter and could not be used any longer.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hf micro-catheter.The device was visually and microscopically inspected for damage.The renegade device showed stretching located 1cm from the hub.Multiple bends and kinks were also confirmed located 114.5cm to the tip.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 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: 17741320
• Report Number: 2124215-2023-49181
• Device Sequence Number: 6877025
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 06/28/2024
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0029854395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 48 KG