MAUDE Adverse Event Report: NAVILYST MEDICAL INC. NAVILYST; BIOFLO PICC WITH ENDEXO TECHNOLOGY

Catalog Number 45-885

Device Problems Inadequate Instructions for Healthcare Professional (1319); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Angiodynamics has modified the included guidewire in their bioflo picc line cat# 45-885 upn#h965458850 so that the included ifu no longer is correct or applies.The instructions included with the catheter are wrong and no correct instructions are provided.I have contacted both the company via their customer support line (they could not give me new instructions) and by my local rep who could give me instructions.Use of the included instructions resulted in two instances of having to revise the picc line due to improper length.

• Brand Name: NAVILYST
• Type of Device: BIOFLO PICC WITH ENDEXO TECHNOLOGY
• Manufacturer (Section D): NAVILYST MEDICAL INC.; 26 forest street; marlborough MA 01752
• MDR Report Key: 5267524
• MDR Text Key: 32753043
• Report Number: MW5058290
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial

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: 07/01/2017
• Device Catalogue Number: 45-885
• Device Lot Number: 4911804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other