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

Model Number UNK761

Device Problems Bent (1059); Entrapment of Device (1212); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

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.At this time it is not possible to assign a definitive root cause for the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

Event description: per email: balloon extractor peeled when inserted into scope was using a navi pro wire md states the extractor feels sticky and when removed the extractor balloon device had peeled back around navi pro wire and broke the wire.Procedure outcome: completed.Was another device needed to completed the procedure: yes.Did anything break off of the device that stayed in the patient post procedure: no.Patient condition was reported to be okay.

Manufacturer Narrative

Device evaluation: as received, the specimen consists of one unidentified hydro gw std an device; returned lodged within the distal 2.5cm of an extractor device, coiled loose, accompanied by a 1.51cm length of detached polymer jacket material and double-bagged within "zip-lock" style poly biohazard pouches.The batch lot was not provided, which prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The specimen presents skive damage 35.0 to 45.2cm from the distal tip exposing 10.2cm of the metallic core wire and additional small areas of jacket removal scattered over the proximal 100cm.The polymer jacket material appears to have been pulled over itself proximally from the distal limit of the skive damage creating and oversized diameter to.04445".The 1.51cm length of detached polymer jacket material presents indications of ductile, tensile overload at each end and a single tear over its entire length.The specimen also presents extensive bend damage located 52.5 to 131.0cm from the distal tip.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), fill catheter or other device with saline solution before and during use to ensure smooth movement of the guidewire within the device." in addition, "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." based on the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.If any further relevant information is provided, a follow up medwatch report will be filed.

• Brand Name: NAVIPRO
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7592954
• MDR Text Key: 111161172
• Report Number: 2126666-2018-00043
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Patient Sequence Number: 1