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

Device Problems Entrapment of Device (1212); Flaked (1246); Stretched (1601); 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; therefore no physical analysis of the device can be performed.The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.As noted in the warnings within the device instructions for use, "free movement of the guidewire within a catheter is an important feature of the 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.The patient information was not provided.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

It was reported that: inside of the lumen, at the hub of the balloon, presented resistance to the wire being passed through.They were eventually able to get the wire down through the hub of the catheter but then the wire proceeded to get stuck in the balloon.So, they cut the hub of the balloon catheter off and then tried to back the rest of the balloon off of the wire.They were able to do it but then in doing so it stuck to the wire and they had to pull off piece by piece the balloon.They completed the procedure with a new balloon.This happened during the procedure and inside the patient's body.No complication.The patient is fine.The wire that it was used on was a.014 thruway.

Manufacturer Narrative

Device evaluation: as received, the specimen consists of one unknown thruway device; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.The specimen presents kink/bend damage over the distal 5.74cm and scattered over the length of the device with stretched coil damage immediately proximal of the distal joint and offset coil wraps in the proximal marker coil segment.The specimen also presents scraped ptfe coating with coating removal scattered over the coated length of the wire shaft.As noted in the precautions within the device instructions for use, "free movement of the guidewire within a catheter is an important feature of the 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 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.

Event Description

Additional information received from the distributor reported that the thruway device was stuck on the balloon catheter upon receipt.After soaking, the devices were able to be separated.

• 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: 8080204
• MDR Text Key: 129192432
• Report Number: 2126666-2018-00085
• 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: 12/21/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1