MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PTFE COATED GUIDEWIRE

Model Number GWF-35-22015

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The catheter kinked at 1,030 mm from the tip, so it became unusable and was replaced with a new catheter.The procedure was completed without any problems with the new guidewire.Additional/amended information - 29-nov-2022: core wire was stick out of the coil, and the guidewire was kinked at 1,030 mm from the tip.So, it became unusable and was replaced with a new guidewire.The procedure was completed without any problems with the new guidewire.

Manufacturer Narrative

No device was returned for analysis.As reported: core wire was stick out of the coil, and the guidewire was kinked at 1,030 mm from the tip.So, it became unusable and was replaced with a new guidewire.The procedure was completed without any problems with the new guidewire.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation "excessive force used", "material fatigue" and/or "improper use", may have impacted on the event as reported.

Event Description

The catheter kinked at 1,030 mm from the tip, so it became unusable and was replaced with a new catheter.The procedure was completed without any problems with the new guidewire.Additional/amended information - 29-nov-2022 core wire was stick out of the coil, and the guidewire was kinked at 1,030 mm from the tip.So, it became unusable and was replaced with a new guidewire.The procedure was completed without any problems with the new guidewire.

Manufacturer Narrative

The observation made during the investigation determined that the returned guidewire was bent on the main body.The j shape was under-formed.There was no evidence of the core wire sticking out from the coil when visually and microscopically examined.Both the distal and proximal joints were intact passing finger pull test, which confirmed guidewire was not fractured.A blood like substance was noted in the pouch and on the inner side of the dispenser tube, which would indicate that the guidewire was used in a medical procedure.No other damage was noted on the returned product.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation "excessive force used", "improper use", "improper handling", "user failure in preparations for use" and/or "improper removal from packaging" may have impacted on the event as reported.

Event Description

The catheter kinked at 1,030 mm from the tip, so it became unusable and was replaced with a new catheter.The procedure was completed without any problems with the new guidewire.Additional/amended information - (b)(6) 2022 core wire was stick out of the coil, and the guidewire was kinked at 1,030 mm from the tip.So, it became unusable and was replaced with a new guidewire.The procedure was completed without any problems with the new guidewire.

Manufacturer Narrative

The observation made during the investigation determined that the returned guidewire was bent on the main body.The j shape was under-formed.There was no evidence of the core wire sticking out from the coil when visually and microscopically examined.Both the distal and proximal joints were intact passing finger pull test, which confirmed guidewire was not fractured.A blood like substance was noted in the pouch and on the inner side of the dispenser tube, which would indicate that the guidewire was used in a medical procedure.No other damage was noted on the returned product.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation "excessive force used", "improper use", "improper handling", "user failure in preparations for use" and/or "improper removal from packaging" may have impacted on the event as reported.

• Brand Name: PTFE COATED GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, ireland Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, ireland Y34 K 825; EI Y34 K825
• Manufacturer Contact: glenn phelan ; butlersland; new ross; co. wexford, ireland Y34 K-825 ; EI Y34 K825
• MDR Report Key: 15957890
• MDR Text Key: 307816408
• Report Number: 9681477-2022-00018
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K935170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWF-35-22015
• Device Lot Number: 7051806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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