MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WI-BOX; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number	C12783
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a cfr/imr procedure, communication issues resulted in the procedure being cancelled.The non-abbott (coroventis) system did not detect an ao signal from the transducer.The pressure wire was exchanged but the issue was not resolved.The non-abbott (coroventis) system was working as expected and the issue was deemed to be due to the wi-box.The procedure was cancelled due to no ao signal.There were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One wi-box (b)(6) was received for analysis, with no accessories or original packaging available for inspection.The results of the hardware evaluation concluded that the returned wi-box functioned as intended.It was verified that no visible hardware issue or any unexpected behavior were identified during the hardware evaluation.Based on the information provided to abbott and the investigation performed, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: WI-BOX
• Common Device Name: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21561240
• Report Number: 2184149-2025-00045
• Device Sequence Number: 4430455
• Product Code: DRG
• UDI-Device Identifier: 05414734054140
• UDI-Public: 05414734054140
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Model Number: C12783
• Device Catalogue Number: C12783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown