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

Model Number M00556201

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2020

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 lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A review of the manufacturing processes indicates that during manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.As indicated in the precautions section of the device instructions for use (dfu), do not advance, withdraw or torque the guidewire against resistance until the cause of the resistance has been determined and confirm that the interventional devices are compatible with the guidewire diameter before use.As described in the operational instructions, fill catheter or other device with saline solution before and during use to ensure smooth movement of the guidewire within the device and note: if movement of the guidewire within the device becomes diminished, remove the guidewire and reactivate the hydrophilic coating by wetting its entire surface with saline solution.At this time, it is not possible to assign a definitive root cause for the event as reported.The patient information was not provided at the time of this report.If any further relevant information is provided, a follow up medwatch report will be submitted.

Event Description

Event description: per cnf, it was reported that: the navipro wire in stuck in the wire channel in trutome.Could not pull out.Additional information received via email on march 23, 2020, reported that the navipro was stuck inside the truetome.The procedure was completed with a second navipro and a second truetome.

Manufacturer Narrative

Device evaluation: as received, the specimen was reported to consist of one-1 each hydro gw std s 260-025; returned coiled, loose, with an adhesive tape tag indicating the customer complaint # secured to the proximal end and triple-bagged within "zip-lock" style poly biohazard pouches.The "trutome" noted in the complaint narrative was not included with the returned specimen; however, the distributor reported that the specimen wire was received lodged within the trutome.The specimen device appeared visually and dimensionally correct for a hydro gw std s 260-035 device not the as reported hydro gw std s 260-025 device.The lack of lot traceability prevents performing a device history records review for 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 specimen presented irregular bends over the distal 14.5cm, and imbedded deposits of green foreign material at 15.1 to 15.5cm, 19.6 to 19.9cm, 25.0 to 25.1cm and 26.5 to 26.6cm from the distal tip.The green foreign material is inconsistent with anything the product would come in contact with in the cleanroom manufacturing and packaging environments.The specimen also presented adhesive residue from the label tag at the proximal end.There was no mention of foreign material in the complaint narrative; as such it is likely to have been incurred during post-event handling.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.As indicated in the precautions section of the device instructions for use (dfu), "do not advance, withdraw or torque the guidewire against resistance until the cause of the resistance has been determined and confirm that the interventional devices are compatible with the guidewire diameter before use.As described in the operational instructions, fill catheter or other device with saline solution before and during use to ensure smooth movement of the guidewire within the device and note: if movement of the guidewire within the device becomes diminished, remove the guidewire and reactivate the hydrophilic coating by wetting its entire surface with saline solution." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appeared that clinical and/or procedural factors have contributed to the event as reported.If there is any further relevant information received, 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
• MDR Report Key: 9879552
• MDR Text Key: 186734741
• Report Number: 2126666-2020-00021
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K124052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

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: M00556201
• Device Catalogue Number: 56-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1