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

Model Number	29420
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device separation occurred.A 135cmx10cm renegade hi flo was selected for use.During the procedure, it was noted that a separation of the hydrophilic coating was seen near the entry port.The procedure was completed with another renegade hi flo.There were no patient complications reported 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17461757
• Report Number: 2124215-2023-39140
• Device Sequence Number: 16821748
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 08/04/2023

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: 01/06/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0026758683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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 Sex: Unknown