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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

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

It was reported that the jetstream catheter got stuck on the wire while they were trying to come out.It would not come out.They did an atherectomy on the patient.After they were done, they were coming out and the wire was stuck to the catheter.The catheter and wire ended up having to come out all together instead of leaving the wire down and coming out over the wire.It was stuck.They had to take everything out and rewire it.They ended up using another wire and they ballooned it.They were almost done with it and finish.The patient was fine.No adverse event.

Manufacturer Narrative

Device evaluation: 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.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 at lake region medical and was determined to be acceptable.The specimen presents kinks/bends of varying severity and frequency scattered over the length of the specimen device.The specimen also presents scraped ptfe coating with coating removal at the apex of the kink damage sites.Deposits of dried blood-like material are scattered over the length of the specimen device.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 relvant information received, 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: 8115852
• MDR Text Key: 129466633
• Report Number: 2126666-2018-00087
• 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: 12/07/2018

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: 02/28/2021
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 10971200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR