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

Model Number M00556231

Device Problem Entrapment of Device (1212)

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

Event Date 04/12/2024

Event Type  malfunction  

Event Description

Event description: ecn event description: during procedure, the navipro wire wouldn't load down the autotome.Wire got stock and woulnd't advance or pull out of catheter.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wet wire good, attempted to flush wire channel, pull and pushed wire in both directions and didn't budge.What is the next course of action?: grabbed new wire and tome.Patient present at time of event?: yes patient complications: no patient complications device 1 of 2 additional information provided 18 april 2024: 1.Received confirmation that the second device was the autotome rx 44.2.The procedure was completed with a jagwire revolution guidewire.19 april 2024: per sales rep, the dfu was followed and wire got stuck within the autotome during insertion.When they grabbed a new wire and tome they had no issues.

Manufacturer Narrative

It was reported that the device was disposed; therefore, no physical analysis of the device can be performed.A review of the device history records of the specimen device performed by juarez does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing the production operators are instructed to 100% visually and tactually inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As indicated in preparation for use (dfu): 1.Before removing the hydrophilic guidewire from its dispenser, inject sterile heparinized saline solution into the luer lock hub end of the dispenser.2.Inject enough solution to fill the dispenser coil.This will completely cover the guidewire surface and activate the hydrophilic coating.3.Remove the hydrophilic guidewire from its dispenser by gently withdrawing the wire's tip.4.If the hydrophilic guidewire cannot easily be removed from its dispenser, inject more heparinized saline solution into the dispenser and then try again.As indicated in directions for use (dfu): 1.Fill catheter or other device with heparinized saline solution before and during use to ensure smooth movement of the hydrophilic guidewire within the device.2.When wet with saline solution or blood, the hydrophilic guidewire will become lubricious.Use of sterilized gauze moistened with heparinized saline solution facilitates handling the wire.3.Insert the guidewire into the device and advance to desired position.Note: if movement of the wire within the device becomes diminished, remove the guidewire and reactivate the hydrophilic coating by wetting its entire surface with heparinized saline solution.At this time, it is not possible to assign a definitive root cause for the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• 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): VENUSA DE MEXICO S. DE R.L. DE C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 19209386
• MDR Text Key: 342007215
• Report Number: 9680001-2024-00011
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729839910
• UDI-Public: 08714729839910
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2024

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: M00556231
• Device Catalogue Number: 5623
• Device Lot Number: JRZ8894789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2024
• 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