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

Model Number	29460
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.A renegade hi-flo kit was selected for use in the liver.During unpacking, it was noted that a section of guidewire had no coating.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: under 18 years.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
A2 - age at time of event: under 18 years.E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Inspection of the device revealed a shaft fracture and stretching inside the carrier hoop.Received guidewire showed no signs of damage or irregularities.Inspection of the device revealed a fractured/stretched shaft located at 16.7 cm to 24.5 cm from the strain relief.Media was returned in the form of a photo.The photo was reviewed which showed the device was fractured.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that coating issue occurred.A renegade hi-flo kit was selected for use in the liver.During unpacking, it was noted that a section of guidewire had no coating.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 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 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: 20152262
• Report Number: 2124215-2024-54573
• Device Sequence Number: 18207567
• 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): 10/21/2024

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 Expiration Date: 10/11/2025
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0032627349
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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: Male