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

Model Number	29420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 25apr2023.It was reported that the head end connector was separated.A 135/10 renegade hi-flo was selected for hepatic arteriography embolization.During unpacking, it was noted that the head end connector was separated at about 1.5cm from the hub.The procedure was completed using another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed a device fracture located 2cm from the hub and 33.8cm from the hub.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The shipping hoop was hydrated, and the device was removed with no issues.The device was inspected for any damage or irregularities.The device showed stretching and a fracture located 2cm from the hub and 33.8cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for shaft damage.No other issues were identified during the product analysis.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16952598
• Report Number: 2124215-2023-22525
• Device Sequence Number: 7040978
• 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
• Report Date (Section B): 05/18/2023

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: 10/23/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0028436492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 69 KG