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

Model Number M00556241

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

The device was not received for evaluation and was reported to have been disposed; 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 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.As indicated in the device instructions for use (dfu) warnings, "to prevent possible tissue damage, care should be taken manipulating a device over a guidewire during the device's placement and withdrawal.If resistance is felt during the device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the guidewire and device as a unit to prevent possible damage and/or complications." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, it appears that device interface and procedural factors impacted on the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

During the ercp, the physician cannulated the bile duct and placed the wire into the bile duct, and advanced it up into the intrahepatic ducts.The physician then exchanged for a tandem xl cannula and was advancing the cannula down the olympus 180 duodenoscope.He realized at the time that the olympus scope elevator broke during this process.He believes that because the olympus elevator broke that as he was advancing the tandem cannula down the scope, the olympus elevator was not holding the wire in place, however (unbeknownst and unwanted by the physician) the wire was advancing deep into the intrahepatic ducts while he was passing the cannula.It was believed that the wire punctured the liver capsule as a result of the broken olympus elevator not holding the wire in place, as he was advancing the cannula down the working channel of the scope.The physician, once noticing how the wire might have punctured the liver capsule, injected contract to complete a cholangiogram.Contrast extravagated outside of the liver, proving that the navipro wire punctured the liver capsule.An advanix plastic stent was placed to relieve the obstruction and help the bile duct decompress, also as an attempt to help the liver puncture site heal.The patient recovered well immediately following the procedure, however his blood count dropped several hours after the procedure, a ct was performed showing a collection, and the patient received blood transfusion.It is believed that the bleeding has stopped at this time and the patient is continuing to recover well.The procedure was completed successfully.

• Brand Name: NAVIPRO
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, mn ; 6418518
• MDR Report Key: 10391384
• MDR Text Key: 202751999
• Report Number: 2126666-2020-00052
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729839927
• UDI-Public: 08714729839927
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00556241
• Device Catalogue Number: 5624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/11/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR