MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number M001491571

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

Event description: 'having issues with rosen wires - we had 3 today that have bent in weird ways.All for the same lot' 'when taking wire out of body they are ending and the inner core is sticking out' what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none what is the next course of action?: none patient present at time of event?: yes patient complications: no patient complications.Event date: (b)(6) 2022.

Manufacturer Narrative

No device was returned.As reported: "event description: ecn event description: 'having issues with rosen wires - we had 3 today that have bent in weird ways.All for the same lot' 'when taking wire out of body they are ending and the inner core is sticking out' what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none what is the next course of action?: none patient present at time of event?: yes patient complications: no patient complications.Event date: (b)(6) 2022." a review of the device history records for 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 (b)(6) 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, 'unknowing/unclear due to insufficient information'' may have impacted on the event as reported.

Event Description

Event description: 'having issues with rosen wires - we had 3 today that have bent in weird ways.All for the same lot' 'when taking wire out of body they are ending and the inner core is sticking out' what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none what is the next course of action?: none patient present at time of event?: yes patient complications: no patient complications event date: (b)(6)2022.

Manufacturer Narrative

No device was returned.As reported: "event description: ecn event description: 'having issues with rosen wires - we had 3 today that have bent in weird ways.All for the same lot' 'when taking wire out of body they are ending and the inner core is sticking out' what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none what is the next course of action?: none patient present at time of event?: yes patient complications: no patient complications event date: (b)(6)2022" a review of the device history records for 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, [?]'unknowing/unclear due to insufficient information'' may have impacted on the event as reported.

• Brand Name: STARTER 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, Y34 K-825 ; EI Y34 K825
• MDR Report Key: 15691220
• MDR Text Key: 307108203
• Report Number: 9681477-2022-00015
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729743309
• UDI-Public: (01)08714729743309(17)250831(10)7068788
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001491571
• Device Lot Number: 7068788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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