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

Model Number	29460
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.A renegade hi flo 135/10 kit was selected for use.During the procedure, it was noted that the pre-packaged guidewire could not be advanced, and then discovered that it was fractured.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that guidewire fracture occurred.A renegade hi flo 135/10 kit was selected for use.During the procedure, it was noted that the pre-packaged guidewire could not be advanced, and then discovered that it was fractured.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection of the device revealed a fractured and stretched shaft of the microcatheter and no guidewire damage.The microcatheter and guidewire were received still inside the carrier hoop with no blood.Microscope inspection of the device revealed a fractured/stretched shaft located at 4 cm to 8.5 cm from the strain relief.There was also a shaft kink located at 2.8 cm from the strain relief.No other issues were identified with the device and no patient complications were reported.

• 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: 20526048
• Report Number: 2124215-2024-63641
• Device Sequence Number: 9070439
• 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): 12/04/2024

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: 02/05/2026
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0033362682
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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