MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported: event description: ecn event description: dr advanced the bentson wire down the drain tube (cook drainage catheter) like they always do to exchange drains.The wire then was getting stuck in the drainage catheter and would not come out.The wire then separated and had to be pulled out in a long 'string' like fashion as the wire unraveled.This has now happened on 2 occasions with the same lot number of this bentson wire with 2 different drains.Both with the same md.The second drain was a merit resolve catheter and the wire did the same thing.The account is questioning if something has changed with the coating on the wire? the account has 14 more of these same lot number wires they would like to return and exchange for 3 new box(s) of bentsons please.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was stuck and would not come out.Had to pull hard and separate the wire.What is the next course of action?: opened a different wire from another vendor of the same size wire and exchanged the drain without any issue.Patient present at time of event?: yes patient complications: no patient complications event date: (b)(6) 2022.Device/procedure outcome: unable to use device - attempted,non bsc product used,procedure completed patient outcome: no value found." " 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 or Problem Description
Event description: ecn event description: dr advanced the bentson wire down the drain tube (cook drainage catheter) like they always do to exchange drains.The wire then was getting stuck in the drainage catheter and would not come out.The wire then separated and had to be pulled out in a long 'string' like fashion as the wire unraveled.This has now happened on 2 occasions with the same lot number of this bentson wire with 2 different drains.Both with the same md.The second drain was a merit resolve catheter and the wire did the same thing.The account is questioning if something has changed with the coating on the wire? the account has 14 more of these same lot number wires they would like to return and exchange for 3 new box(s) of bentsons please.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was stuck and would not come out.Had to pull hard and separate the wire.What is the next course of action?: opened a different wire from another vendor of the same size wire and exchanged the drain without any issue.Patient present at time of event?: yes patient complications: no patient complications.Event date: (b)(6) 2022.
Additional Manufacturer Narrative
As reported: event description: ecn event description: dr advanced the bentson wire down the drain tube (cook drainage catheter) like they always do to exchange drains.The wire then was getting stuck in the drainage catheter and would not come out.The wire then separated and had to be pulled out in a long 'string' like fashion as the wire unraveled.This has now happened on 2 occasions with the same lot number of this bentson wire with 2 different drains.Both with the same md.The second drain was a merit resolve catheter and the wire did the same thing.The account is questioning if something has changed with the coating on the wire? the account has 14 more of these same lot number wires they would like to return and exchange for 3 new box(s) of bentsons please.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was stuck and would not come out.Had to pull hard and separate the wire.What is the next course of action?: opened a different wire from another vendor of the same size wire and exchanged the drain without any issue.Patient present at time of event?: yes patient complications: no patient complications event date: 2022-8-19 device/procedure outcome: unable to use device - attempted,non bsc product used,procedure completed patient outcome: no value found." 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 or Problem Description
Event description: ecn event description: dr advanced the bentson wire down the drain tube (cook drainage catheter) like they always do to exchange drains.The wire then was getting stuck in the drainage catheter and would not come out.The wire then separated and had to be pulled out in a long 'string' like fashion as the wire unraveled.This has now happened on 2 occasions with the same lot number of this bentson wire with 2 different drains.Both with the same md.The second drain was a merit resolve catheter and the wire did the same thing.The account is questioning if something has changed with the coating on the wire? the account has 14 more of these same lot number wires they would like to return and exchange for 3 new box(s) of bentsons please.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was stuck and would not come out.Had to pull hard and separate the wire.What is the next course of action?: opened a different wire from another vendor of the same size wire and exchanged the drain without any issue.Patient present at time of event?: yes patient complications: no patient complications event date: 2022-8-19.
Event or Problem Description
Event description: ecn event description: dr advanced the bentson wire down the drain tube (cook drainage catheter) like they always do to exchange drains.The wire then was getting stuck in the drainage catheter and would not come out.The wire then separated and had to be pulled out in a long 'string' like fashion as the wire unraveled.This has now happened on 2 occasions with the same lot number of this bentson wire with 2 different drains.Both with the same md.The second drain was a merit resolve catheter and the wire did the same thing.The account is questioning if something has changed with the coating on the wire? the account has 14 more of these same lot number wires they would like to return and exchange for 3 new box(s) of bentsons please.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was stuck and would not come out.Had to pull hard and separate the wire.What is the next course of action?: opened a different wire from another vendor of the same size wire and exchanged the drain without any issue.Patient present at time of event?: yes patient complications: no patient complications event date: (b)(6) 2022.
Additional Manufacturer Narrative
As reported: event description: ecn event description: dr advanced the bentson wire down the drain tube (cook drainage catheter) like they always do to exchange drains.The wire then was getting stuck in the drainage catheter and would not come out.The wire then separated and had to be pulled out in a long 'string' like fashion as the wire unraveled.This has now happened on 2 occasions with the same lot number of this bentson wire with 2 different drains.Both with the same md.The second drain was a merit resolve catheter and the wire did the same thing.The account is questioning if something has changed with the coating on the wire? the account has 14 more of these same lot number wires they would like to return and exchange for 3 new box(s) of bentsons please.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was stuck and would not come out.Had to pull hard and separate the wire.What is the next course of action?: opened a different wire from another vendor of the same size wire and exchanged the drain without any issue.Patient present at time of event?: yes patient complications: no patient complications event date: 2022-8-19 device/procedure outcome: unable to use device - attempted,non bsc product used,procedure completed patient outcome: no value found." " 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.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: 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 ; 3530514405
• MDR Report Key: 15416295
• Report Number: 9681477-2022-00013
• Device Sequence Number: 6507636
• Product Code: DQX
• UDI-Device Identifier: 08714729743392
• UDI-Public: (01)08714729743392(17)250531(10)7011852
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: M001491751
• Device Lot Number: 7011852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 09/26/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/27/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown