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

Model Number	M001182880
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that markerband issue occurred.A 135/10 renegade hi-flo was selected for use in the interventional therapy for liver cancer.During the procedure, the mark point which is a radiographically opaque marker used for localization was found to be abnormal.The microcatheter pressed against the micro guidewire causing the mark point to be out of position.The guidewire and microcatheter were withdrawn and the microcatheter was found to be kinked.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual and microscopic inspections found kinks located at 1.8, 18.5, 36.8 and 129.8 to 131cm from the microcatheter hub, with one being a larger flattened impression observed near the distal tip.The marker band was 1mm from tip and had no abnormalities.No other issues were identified with the device.
Event or Problem Description
It was reported that markerband issue occurred.A 135/10 renegade hi-flo was selected for use in the interventional therapy for liver cancer.During the procedure, the mark point which is a radiographically opaque marker used for localization was found to be abnormal.The microcatheter pressed against the micro guidewire causing the mark point to be out of position.The guidewire and microcatheter were withdrawn and the microcatheter was found to be kinked.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• 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: 20698452
• Report Number: 2124215-2024-70669
• Device Sequence Number: 11708042
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• 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): 12/10/2024

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 Model Number: M001182880
• Device Catalogue Number: M001182880
• Device Lot Number: 0032886433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/23/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2023
• 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: Female