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

Model Number M00556231

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

As received, the specimen consisted of one-1 each hydro gw std an 260-035; returned reloaded into dispenser assembly; double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented a ductile/tensile overload fracture of the polymer jacket with material removal, exposing 0.2 cm of the metallic core wire at the distal end; the polymer jacket material distal of the fracture was not returned with the specimen.A review of the device history records of the specimen device 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 tactilely 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.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the limited event information provided and the as-received condition of the device, it appeared that handling factors and/or preparation for use factors have contributed to the event as reported.The ductile/tensile overload fracture of the polymer jacket with material removal is representative of removing the guidewire from the dispenser without proper hydration.As per 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.Should additional event information become available, a follow up medwatch report will be filed.

Event Description

Event description: wire tip was frayed during ercp.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: n/a what is the next course of action?: opened up another of the same patient present at time of event?: yes patient complications: no patient complications was issue present upon opening package?: no photo or video of issue: no.

• 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: 18650973
• MDR Text Key: 334659255
• Report Number: 9680001-2024-00003
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/06/2024

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: JRZ8688654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• 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