MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	PG14300LF
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
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.Device is expected to return for evaluation.
Event or Problem Description
The phoenix wire was lock to the phoenix catheter at the end of final run.The wire, and the catheter was removed with no issues.The rest of the procedure was completed with balloon.Associated with phoenix catheter (phoenix catheter system, 1.8mm) complaint (b)(4).No patient injury.Date of occurrence: (b)(6) 2020.Date of awareness: 8/27/2020.As per complaint file, (b)(6) responded: please confirm if there was a phoenix wire failure as well? the way i was told, it was a wire lock due to coating failure.Please explain how did the device fail? the way i was told, it was a wire lock due to coating failure.
Additional Manufacturer Narrative
Device is not available for return, appropriate codes completed.
Event or Problem Description
The phoenix wire was lock to the phoenix catheter at the end of final run.The wire and the catheter was removed with no issues.The rest of the procedure was completed with balloon.Associated with phoenix catheter (phoenix catheter system, 1.8mm) complaint (b)(4).No patient injury.Date of occurrence: (b)(6) 2020.Date of awareness: 8/27/2020.As per complaint file - dan lang responded: -please confirm if there was a phoenix wire failure as well? the way i was told, it was a wire lock due to coating failure.-please explain how did the device fail? the way i was told, it was a wire lock due to coating failure.

• Brand Name: PHOENIX 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: 10572383
• Report Number: 9681477-2020-00013
• Device Sequence Number: 11548026
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)210115(10)10950858
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080144
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 01/15/2021
• Device Model Number: PG14300LF
• Device Lot Number: 10950858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHOENIX CATHETER SYSTEM, 1.8MM; PHOENIX CATHETER SYSTEM, 1.8MM; PHOENIX CATHETER SYSTEM, 1.8MM