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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation; therefore no physical analysis of the device can be performed.The lot number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.A review of the manufacturing processes indicates that during manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.As noted in the device instructions for use (dfu), "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.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

The stent delivery system locked on the wire after the deployment of the stent.The roller ball delivery system also did not fully deploy the stent and had to use the blue pull stick to fully deploy/ release the stent.It was noted that the stent slightly elongate during deployment.Status: patient is fine.Nothing further was required.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one each unidentified thruway device; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The stent delivery system noted in the complaint was not returned with the specimen thruway device.The lot number is unknown; therefore, the manufacturing batch records for the complaint device cannot be reviewed.A review of the manufacturing processes indicates that during manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The specimen presents extensive kink/bend damage over the length of the device.The specimen also presents scraped ptfe coating scattered over the length of the specimen, including coating removal at the severe kink damage.The distal coil presents stretched coil wraps immediately distal of the proximal coil to core joint.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.As noted in the device instructions for use (dfu), "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 to date, it appears that clinical and/or procedural factors have contributed to 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
• MDR Report Key: 10149860
• MDR Text Key: 195375785
• Report Number: 2126666-2020-00035
• 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: 07/16/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1