MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491651
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Awaiting device return for further analysis.
Event or Problem Description
Event description: per medwatch, it was reported that: describe the event or problem or problem: elderly male with history of hypertension and recent chest pain.Procedure is percutaneous intervention-balloon angioplasty with stent placement.When the package of the bsc guidewire was opened, the j wire was broken/bent.Not used on patient.What was the original intended procedure? : percutaneous intervention - balloon angioplasty with stent placement.What problem did the user have (check all that apply) : device failed (e.G.Broke, couldn't get it to work or stopped working).
Additional Manufacturer Narrative
No product was provided for analysis.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, "excessive force used" and/or "improper use" may have impacted on the event as reported.
Event or Problem Description
Event description: per medwatch, it was reported that: describe the event or problem or problem: elderly male with history of hypertension and recent chest pain.Procedure is percutaneous intervention-balloon angioplasty with stent placement.When the package of the bsc guidewire was opened, the j wire was broken/bent.Not used on patient.What was the original intended procedure? percutaneous intervention - balloon angioplasty with stent placement.What problem did the user have (check all that apply) : device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• MDR Report Key: 11580230
• Report Number: 9681477-2021-00004
• Device Sequence Number: 17363985
• Product Code: DQX
• UDI-Device Identifier: 08714729743330
• UDI-Public: (01)08714729743330(17)231130(10)5999760
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 11/30/2023
• Device Model Number: M001491651
• Device Lot Number: 5999760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 77