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

Model Number M001492831

Device Problems Bent (1059); Flaked (1246); Stretched (1601); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation; therefore no physical analysis of the device can be performed.However, an image of the specimen device was provided.The supplied image presents a fracture of the core wire with concurrent coil stretching, bend damage distal of the core wire fracture and kink damage proximal of the core wire fracture.The batch 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.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

The wire core at tip was unraveled.Could not use.Opened another one to do case.Additional information reported there were no patient complications and the patient's condition post procedure was fine.The issue occurred during prep and outside the patient when pulling the device out of the hoop.

Manufacturer Narrative

Device evaluation: the batch number remains unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.As received, the specimen consists of one 300-018 short taper g.W.; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents a core wire fracture with concurrent coil stretching, bend/kink damage of varying severity and frequency scattered over the length of the device.The inner aspect of the bend/kink damage located 12.5 to 13.5cm from the proximal end presents scraped/abraded ptfe coating, consistent with abrading against another surface.The exposed distal end of the core wire presents indications of ductile tensile overload (reduction in cross-sectional area / necking).The coil wraps adjacent to the distal tip joint were stretched to expose the proximal aspect of the distal tip joint to reveal a core wire ductile, tensile overload.No other damage or inconsistencies are noted to the specimen at this time.The proximal coil to core wire joint appears 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 evidence presented by the sample and the information provided by the supporting documentation, handling factors appear to have impacted on the event as reported.If there is any further relevant information provided a follow up 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: 7272973
• MDR Text Key: 100441942
• Report Number: 2126666-2018-00009
• 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: 03/13/2018

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: M001492831
• Device Catalogue Number: 49-283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1