MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2525XF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.However, the device was used past its expiry date 01 july 2021.The reported event date is (b)(6) 2021.Awaiting device return to complete investigation.
Event or Problem Description
The distal part of the wire broke off inside the body.They removed the piece of the wire from inside the body through surgery.
Additional Manufacturer Narrative
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.However, the device was used past its expiry date 01 july 2021.The reported event date is (b)(6) 2021.Customer confirmed the device is not available for return.
Event or Problem Description
The distal part of the wire broke off inside the body.They removed the piece of the wire from inside the body through surgery.
Event or Problem Description
The distal part of the wire broke off inside the body.They removed the piece of the wire from inside the body through surgery.
Additional Manufacturer Narrative
B3 event date updated as additional information received.

• 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: 12230871
• Report Number: 9681477-2021-00013
• Device Sequence Number: 1323719
• Product Code: DQX
• UDI-Device Identifier: 10845225002746
• UDI-Public: (01)10845225002746(17)210701(10)1107419
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: OFG2525XF
• Device Catalogue Number: PG14300XF
• Device Lot Number: 11007419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/03/2021; 10/01/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/21/2021; 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention