MAUDE Adverse Event Report: ST. JUDE MEDICAL WI-BOX

Lot Number 5710461

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

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 determined.

Event Description

During a cmd measurement procedure, all the pressuerwires were prepped and ready for connection with the system.When the system was powered on, the wi-box light flashed green briefly, then turned yellow and no connection could be established between the wi-box, pressurewire, or corohub.A second attempt was made to establish connection, but the issue persisted.A second pressurewire was opened and connection was attempted, but the issue continued.During troubleshooting it was determined that the issue was trace to an unstable connection of the wi-box to the corohub.Once this connections was confirm, a third pressurewire was used and the procedure was able to be completed with no adverse patient consequences.Due to these issues a procedure delay occurred.

• Brand Name: WI-BOX
• Type of Device: WI-BOX
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12931283
• MDR Text Key: 283244707
• Report Number: 2184149-2021-00381
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2021

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
• Device Operator: Health Professional
• Device Lot Number: 5710461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1