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

Model Number 29462

Device Problems Break (1069); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2020

Event Type  malfunction  

Event Description

It was reported that the microcatheter was fractured.A renegade hi-flo fathom system was selected for use.After opening the sterile packaging, removal of the microcatheter was difficult and upon removal, it was noted that the catheter became separated into two pieces.Another catheter was used successfully.The device was not used on the patient.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that the microcatheter was fractured.A renegade hi-flo fathom system was selected for use.After opening the sterile packaging, removal of the microcatheter was difficult and upon removal, it was noted that the catheter became separated into two pieces.Another catheter was used successfully.The device was not used on the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the microcatheter was fractured.A renegade hi-flo fathom system was selected for use.After opening the sterile packaging, removal of the microcatheter was difficult and upon removal, it was noted that the catheter became separated into two pieces.Another catheter was used successfully.The device was not used on the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a fracture in the outer shaft located 5mm from the strain relief, outer shaft damage (stretched) for 16mm, and the inner shaft was stretched between the outer shaft fracture faces.Inspection of the rest of the device found no other damage or defect.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10514674
• MDR Text Key: 206331860
• Report Number: 2134265-2020-12586
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729790853
• UDI-Public: 08714729790853
• Combination Product (y/n): N
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0024635859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/11/2020; 10/08/2020
• Supplement Dates FDA Received: 09/17/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1