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

Model Number 29420

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 19jul2022.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 22.7cm from the hub.

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 hi flo was received completely removed from the shipping hoop.A fracture 22.7 cm from the hub was visible.The strain relief was noted to be on the distal portion of the fracture and not on the hub.Signs of stretching were noted 16.4 cm from the hub.Of note, signs of saline were seen on the distal portion of the catheter, but the proximal end of the catheter showed no signs of saline.Because there was no evidence of any product quality deficiencies, it was considered likely that the fractures and stretching attributable to handling issues.This concludes the product analysis.

• Brand Name: RENEGADE HI-FLO
• Type of Device: 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: 15193535
• MDR Text Key: 304907068
• Report Number: 2134265-2022-08402
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280590
• UDI-Public: 08714729280590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0028570196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1