MAUDE Adverse Event Report: MYELOTEC, INC 2017 NAVICATH KIT; CATHETER WITH COMPONENTS

Catalog Number 2017

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.

Event Description

Introducer provided broke off during extraction procedure.

• Brand Name: 2017 NAVICATH KIT
• Type of Device: CATHETER WITH COMPONENTS
• Manufacturer (Section D): MYELOTEC, INC; 4000 northfield way; suite 900; roswell GA 30076
• Manufacturer (Section G): MYELOTEC, INC; 4000 northfield way; suite 900; roswell GA 30076
• Manufacturer Contact: richard wunderlich ; 4000 northfield way; suite 900; roswell, GA 30076 ; 7706644656
• MDR Report Key: 6490750
• MDR Text Key: 72936477
• Report Number: 1062474-2017-00004
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K980734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 2017
• Device Lot Number: 5158/MY28416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2016
• 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