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

Model Number M001492971

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Reportable based on the device evaluation.The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.As received, the specimen consists of one-1 300-014 gw, short taper; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents numerous bends/kinks of varying severity and frequency, beginning at the distal tip and scattered over the length of the wire.The specimen also presents scraped/frayed ptfe with coating removal located 48.9 to 83.6cm from the distal tip.No other damage or inconsistencies are noted to the specimen at this time.All joints appear to be correct and intact by visual examination and by non-destructive testing.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, clinical and/or procedural 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 filed.

Event Description

The blades would not respond correctly.When they asked for the blades to go up, they would not go up and when they asked the blades to go down, the blades came up.They pulled another catheter of the same exact kind, completed the procedure and had one problem which was the catheter actually kinking, they're not sure how it kinked.The second one kinked.They were able to finish the procedure with the second device.They're having problems with the jetstream and then realized that the wire was actually messed up when they pulled that wire out that's why they pulled another of the same device and replaced it.This all happened during procedure and the devices were inserted into the patient.Patient is fine.No complications.Additional information: because the jetstream was unresponsive to the blade selection, it was noticed that the wire was kinked in several segments on the distal end of the wire.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• 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: 7486865
• MDR Text Key: 107983715
• Report Number: 2126666-2018-00033
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

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 Model Number: M001492971
• Device Catalogue Number: 49-297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 58 YR