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

Model Number M00556241

Device Problem Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation; therefore no physical analysis of the device can be performed.The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.The device instructions for use state, "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." if there is any further relevant information provided, a follow-up medwatch report will be filed.

Event Description

The wire was in the pancreatic duct to enable the dr to place a stent over it.The nurse noticed that there was resistance when trying to remove the wire and then noticed that the tip of the wire had broken off and the metal wire running inside the stent had become exposed.The dr managed to remove the wire but could not retrieve the tip of the wire that is still left inside the patient.He is bringing the patient back in 4 weeks to try and remove it.It is lying inside the pancreatic duct.Patient condition was reported as stable.

Manufacturer Narrative

Device evaluation: 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.The history records indicate this product was final inspection tested and was determined to be acceptable.As received, the specimen consists of one-1 hydro gw stf std s 260-035; returned coiled loose and double-bagged within "zip-lock" style poly pouches accompanied by the labeled mylar pouch film.After wiping the specimen with a gauze pad soaked with blood-bank saline, the specimen was subjected to visual and tactile examination.The specimen coating appears visually and tactilely consistent when examined at 1x - 18 inches, unaided, wet.The specimen presents skived damage to the polymer jacket exposing the metallic core wire at 3.09mm and 3.58 to 6.13cm from the distal end.Approximately 1.25cm of polymer jacket material and metallic core wire are missing from the distal end.The specimen also presents bend damage over the distal 23.5cm.The core wire fracture presents indications of a low cycle fatigue bending overload.Microscopically the specimen coating appears to be worn and abraded, consistent with clinical use.Except where noted, the specimen device appears visually and dimensionally correct.At this time it is not possible to assign a definitive root cause for the event as reported.As noted in the device instructions for use (dfu) 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 states, "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." based on the information provided, clinical and/or procedural factors appear to have impacted on the event as reported.If additional relevant information is received, a follow up medwatch report will be submitted.

Manufacturer Narrative

Event or problem was updated to include additional information received on 10-30-2017.If there is any further relevant information provided a follow up medwatch report will be submitted.

Event Description

Additional information received on 10-30-2017 indicated that there was an attempt to remove the tip from the patient but was unsuccessful.Patient was discharged home and will return at a later date.

• 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: 6945917
• MDR Text Key: 89269709
• Report Number: 2126666-2017-00103
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2017

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: 06/12/2020
• Device Model Number: M00556241
• Device Catalogue Number: 5624
• Device Lot Number: 10852101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 10/20/2017; 10/30/2017
• Supplement Dates FDA Received: 10/27/2017; 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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): Other; Required Intervention