MAUDE Adverse Event Report: LAKE REGION MEDICAL NAVIPRO; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number M00556211

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation at the time of this report; therefore no physical analysis of the device can be performed.The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.The device instructions for use in the preparation for use section states, " the surface of the guidewire is not lubricious unless it is wet.Before removing the guidewire from its dispenser, inject sterile saline solution into the luer lock hub end of the dispenser using a syringe.Inject enough solution to fill the dispenser coil.This will completely cover the guidewire surface and activate the hydrophilic coating.Remove the guidewire from its dispenser by gently withdrawing the guidewire's tip.If the guidewire cannot easily be removed from its dispenser, inject more saline solution into the dispenser and then try again." the patient information and the event date were not provided at the time of this report.Based on the information received to date an exact root cause cannot be determined; however, it appears that clinical factors may have impacted on the event as reported.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

It was reported that they were trying to get the wire out of the packaging and they could not get the wire out.They tore it or broke it, trying to get it out of the plastic tubing and they had to used another of the same device.The problem was noticed during procedure and it occurred outside of the patient.No consequences or impact to the patient.

• Brand Name: NAVIPRO
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 8248909
• MDR Text Key: 134577760
• Report Number: 2126666-2019-00005
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2019

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 Model Number: M00556211
• Device Catalogue Number: 5621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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