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

Model Number M00556231

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation; therefore no physical analysis of the device can be performed.The manufacturing batch record review confirmed that the device met all material, assembly and inspections.The patient information and event date were reported to be unknown.Product is expected to be returned.If there is any further relevant information provided, a follow-up medwatch report will be provided.

Event Description

When navipro was unpacked, the coating of the tip part was peeled off, so the physician didn't use the device.There was no damage to the patient.

Manufacturer Narrative

Device evaluation: the manufacturing batch record review confirmed that the device met all material, assembly and inspections.As received, the specimen consists of one each hydro gw std an 260-035 device; returned loaded within the dispenser assembly, within the opened, labeled mylar/tyvek packaging pouch and double-bagged within "zip-lock" style poly pouches.As received, the dispenser assembly does not present any residual moisture visible within the tubing lumen typical of flushing the dispenser with saline prior to use.After injecting the dispenser assembly with 12cc of room temperature (22 degrees) blood-bank saline, the specimen was easily removed from the dispenser and 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 3.3mm of the metallic core wire protruding through the polymer jacket at 0.47cm from the distal tip.The polymer jacket presents indications of elastic deformation in the vicinity of the core wire protrusion and a 0.92mm tear immediately distal of the core wire penetration.The tip shape is altered by the damage.Microscopically the specimen coating appears to be smooth and consistent.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.Based on the information provided, handling and or procedural factors appear to have impacted on the event as reported.The event date and patient information were reported to be unknown.If there is any further relevant information received, 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
• 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: 6228612
• MDR Text Key: 64515291
• Report Number: 2126666-2017-00001
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/27/2017

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 Expiration Date: 06/30/2019
• Device Model Number: M00556231
• Device Catalogue Number: 5623
• Device Lot Number: 10706713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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