MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X EP SYSTEM SURFACELINK MODULE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	ENSITE-SRFLNK-01
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a wolff-parkinson-white procedure, there was a signal issue with the ensite x ep system surfacelink module which resulted in a delay of procedure by 1.5 hours.The delta was mapped and successfully eliminated by rf ablation.Later, post ablation, the catheter was found to be too thin.The setup was 7fr but it looked like a 4fr.The signal for the respiratory meter was also abnormal.Then, the intracardiac ecg was observed with artifacts before all signals were gone.The surface ecg signals were also not appearing.The connection of the rl was checked and secured but there was no improvement.However, it was found that there was another accessory pathway which needed mapping.A new surface link module was requested for urgent delivery.While waiting for the new surface link module, the case was continued using cryo instead of 3d mapping for the septal pathway ablation.After the surface link module arrival, mapping could be done and it was found that the cryo was not necessary.The case was then completed successfully with the new surface link and the patient was stable.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one ensitex surfacelink (surflink) module was received for evaluation.The module was recognized upon connection to a test station.Evaluation testing revealed that the surflink primary active patch did not produce an expected signal.The voltage readings measured at the (right leg or neutral) ecg electrical pin verified the electrical pin was non-functional.This non functional pin duplicated the reported symptom.Internal inspection revealed that the connection to the primary pin of the belly patch was loose or not connected causing an electrical open.The returned images confirm that the ecg was non-functional.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to an electrical open to the active belly patch pin from an undetermined event.

• Brand Name: ENSITE¿ X EP SYSTEM SURFACELINK MODULE
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: 17071950
• Report Number: 2184149-2023-00117
• Device Sequence Number: 12285662
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: 05415067033611
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K202066
• 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): 06/21/2023

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: ENSITE-SRFLNK-01
• Device Catalogue Number: ENSITE-SRFLNK-01
• Device Lot Number: 841760001
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown