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

Model Number M00556201

Device Problem Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be received for analysis as it was reported to have been disposed and therefore, no physical or visual analysis of the device can be performed.The manufacturing batch record review confirmed the device met all material, assembly and inspection specifications.As noted in the device instructions for use warnings, "to prevent possible tissue damage, care should be taken when manipulating a device over a guidewire during the device's placement and withdrawal.If resistance is felt during 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.Avoid manipulating and or withdrawing the hydrophilic guidewire back through a metal needle or cannulas.A sharp edge may scrape the coating or shear the guidewire.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the guidewire has been inserted.The precautions section of the dfu state, "do not advance, withdraw, or torque the guidewire against resistance until the cause of the resistance has been determined.Excessive force against resistance may result in damage to the guidewire, interfacing device and/or duct." also noted in the dfu, "caution: inappropriate use of the guidewire may result in wire/tip breakage in the gastrointestinal tract." if there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

A piece of equipment used in an ercp procedure became stuck and the patient then required surgery to remove.

• 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: 6845037
• MDR Text Key: 85001727
• Report Number: 2126666-2017-00077
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

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 Expiration Date: 12/31/2019
• Device Model Number: M00556201
• Device Catalogue Number: 5620
• Device Lot Number: 10777799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention