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

Model Number	C12058
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Related mfr number: 3008452825-2020-00712.During preparation for a coronary flow assessment procedure, while the patient was prepped, the tip of the guidewire was shaped, however when introducing the device, the guidewire was unable to be equalized.The device was replaced, but the same issue occurred.The procedure was cancelled due to this issue.There were no adverse patient consequences due to this event.
Additional Manufacturer Narrative
The reported event of a pressure registration issue could not be confirmed.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.
Additional Manufacturer Narrative
One pressurewire aeris was returned for analysis.Functional testing could not be performed due to the condition of the returned pressurewire.Microscopic inspection revealed a dried salt/fiber-like substance was stuck inside the covering of the sensor element, which could affect wire functionality.It was also not possible to remove the dried salt/fiber-like substance without compromising results from further signal testing.Electrical testing of the guidewire revealed no anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported pressure registration issue remains unknown.

• 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: 11333862
• Report Number: 3008452825-2020-00721
• Device Sequence Number: 16998264
• 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,Followup
• Report Date (Section B): 04/09/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/01/2021; 04/01/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/07/2021; 04/09/2021
• 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: PRESSURE WIRE AERIS G8; PRESSURE WIRE AERIS G8