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

Device Problems Entrapment of Device (1212); Flaked (1246); Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

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.At this time it is not possible to assign a definitive root cause for the event as reported.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." based on the information provided to date, clinical and/or procedural factors appear to have impacted on the event as reported.Patient age was reported to be over 18 years.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

Event description: per email, it was reported that: after doing two passes with the blades off.They had the blades off then they were unable to retract due to the wire spinning within the catheter.This happen during the case.They had to pull the entire device out and they don't have to put in one in.No complication and patient is fine.(b)(6) 2020: as per additional information received: when attempting to rex the jetstream catheter out, the device became stuck onto the thruway wire and we were unable to rex out.The wire and jetstream were removed together as one unit.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one unidentified thruway guidewire; returned coiled, loose and double-bagged in "zip-lock" style poly biohazard pouches.The lot number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.The specimen presents kinks/bends of varying severity and frequency scattered over the length of the specimen.The specimen also presents scraped ptfe coating with coating removal in the vicinity of the kink damage.The distal coil presents adhered biomaterial at the proximal joint and stretched coil wraps distal of the proximal joint.Loosely adhered biomaterial was present between the second distal marker coil and proximal marker coil.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 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 it appears that clinical and procedural factors have contributed to the event as reported.If any further relevant information is 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: 9700386
• MDR Text Key: 185701047
• Report Number: 2126666-2020-00009
• 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: 02/20/2020

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: 02/13/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1