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

Model Number	29420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) university.
Event or Problem Description
It was reported that a tip separation occurred.A 135/10 renegade hi flo was selected for use.During the preparation, it was noted that the tip joint was separated.There were no complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device returned in the shipping hoop.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 a fracture located 5cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was not confirmed for tip separation; however, a fractured shaft was confirmed.
Event or Problem Description
It was reported that a tip separation occurred.A 135/10 renegade hi flo was selected for use.During the preparation, it was noted that the tip joint was separated.The procedure was completed with another renegade hi flo.There were no complications 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16584914
• Report Number: 2124215-2023-11624
• Device Sequence Number: 4747734
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 10/31/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0028476927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 70 KG