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

Model Number	29420
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the renegade hi flo was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The renegade was received partially in the shipping hoop.Two fractures were visible before removing from the hoop.They were located 8.7 cm and 44.1 cm from the hub.A kink was noted 46.8 cm from the hub.The shipping hoop was hydrated and the remaining part of the renegade hi flo was removed with no resistance.Because there was no evidence of any product quality deficiencies, it was considered likely that the fractures and kink attributable to handling issues.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the microcatheter would not release from the hoop.A 105/10 renegade hi-flo microcatheter was selected for use.During unpacking, it was noted that the microcatheter would not release from the hoop.After flushing the inside and the outside of the microcatheter, it would not release.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed microcatheter fracture located at 44.1cm from the hub.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15192775
• Report Number: 2134265-2022-08373
• Device Sequence Number: 5541951
• Product Code: KRA
• UDI-Device Identifier: 08714729280590
• UDI-Public: 08714729280590
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: 04/10/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0027288008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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