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	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 135/10 renegade hi-flo kit was selected for treatment, but it was unable to let other devices cross.Based on the received photo of the complaint device, it was noted that the shaft was broken.Another of the same device was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Ga - mfr site zip/post code: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.A 135/10 renegade hi-flo kit was selected for treatment, but it was unable to let other devices cross.Based on the received photo of the complaint device, it was noted that the shaft was broken.Another of the same device was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
G1 - mfr site zip/post code: (b)(4).Device evaluated by mfr.: device was received for analysis and underwent a visual and microscopic examination.Inspection revealed that the device had a shaft kink and stuck adapter 54.5cm from the hub along with a shaft fracture/stretching located 27.5cm from the hub which was shown in a media that was returned in the form of a photo.The complaint was confirmed for issues due to shaft damage.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19430715
• Report Number: 2124215-2024-32491
• Device Sequence Number: 12845917
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 09/20/2025
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0032472780
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG