MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ASSEMBLY RF GEN II REMOTE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number H700490

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

During the atrioventricular nodal reentrant tachycardia (avnrt) procedure, communication issues resulted in a procedural delay.The ampere generator was unable to connect to the ensite x.Attempted multiple reboots, reseated connections, rebooted the entire system, and started a new study with no resolve.Replaced the ampere fiber, the ampere, the amplifier, and it was still not possible to connect the ampere to the ensite x.The ampere remote was removed, and the ampere connected.The procedure was completed without adverse consequences for the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be 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: ASSEMBLY RF GEN II REMOTE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18841865
• MDR Text Key: 337191575
• Report Number: 2184149-2024-00043
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067004901
• UDI-Public: 05415067004901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110016, P13
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700490
• Device Lot Number: 5892289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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