MAUDE Adverse Event Report: ST. JUDE MEDICAL PRESSURE WIRE AERIS G8; WIRE, GUIDE, CATHETER

Model Number	C12058
Medical Device Problem Codes	Difficult to Insert (1316); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During preparation, the tip of the guidewire was shaped, however when introducing the device, the guidewire was unable to take a reading.The procedure was cancelled due to this issue.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PRESSURE WIRE AERIS G8
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• MDR Report Key: 11107562
• Report Number: 3008452825-2020-00712
• Device Sequence Number: 3922455
• Product Code: DQX
• UDI-Device Identifier: 05414734055772
• UDI-Public: 05414734055772
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K140466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 07/31/2021
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 7121179
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/23/2021
• 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: Other