MAUDE Adverse Event Report: LAKE REGION MEDICAL THRUWAY GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number M001492971

Device Problems Entrapment of Device (1212); Flaked (1246); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation at the time of this report; therefore no physical analysis of the device can be performed.The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications.At this time it is not possible to assign a definitive root cause for the event as reported.The device instructions for use under the precaution section states, "free movement of the guidewire within the catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information.Test the system for any resistance prior to use." if there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

The thruway wire, it was just stuck in the catheter.They opened a new one, another of the same type of devices, same wire and same device to complete the case.There were no complication.Patient was fine.

Manufacturer Narrative

Device evaluation: the manufacturing batch record review confirmed the device met all material, assembly and inspection specifications.As received, the specimen consists of one 300-014 gw, short taper; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents extensive kink/bend damage scattered over the length of the device.The specimen also presents scraped ptfe coating with coating removal scattered over the coated length of the device.Deposits of dried blood-like material are scattered over the length of the specimen device.All joints appear to be correct and intact.Except where noted, the specimen device appears visually and dimensionally correct.The device instructions for use under the precaution section states, "free movement of the guidewire within the catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information.Test the system for any resistance prior to use." at this time it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, procedural and/or clinical factors appear to have impacted on the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8115529
• MDR Text Key: 129154162
• Report Number: 2126666-2018-00086
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K042338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

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: 09/30/2021
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 11057753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1