MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The following was published in the journal wiley in an article titled, "comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation" jan-hendrik schipper md, received: 1 july 2023 | revised: 18 august 2023 | accepted: 28 august 2023 doi: 10.1111/jce.16056.In this retrospective single-center analysis, all consecutive patients undergoing pfa-based de novo pvi between september 2021 and october 2022 in the setting of paroxysmal and persistent atrial fibrillation (paf and persaf) were analyzed and compared to consecutive patients who underwent de novo pvi using the boston scientific polarx cb system in the same time period.After implementation of pfa, less cb pvi were performed hence, for equal comparison one-third of the enrolled patients underwent cb pvi between february and september 2021.All physicians (five different operators) used pfa for the first time.Data acquisition was performed using an electronic data capture system17 (redcap database).The study was approved by the local ethics committee of the university of cologne and complied with the declaration of helsinki.All patients provided written informed consent.Two pericardial tamponades occurred in the pfa group.Of those two pericardial tamponades reported, one was most likely caused by complex tsp and led to surgical treatment.The other pericardial tamponade occurred on the day after pvi and was managed by pericardiocentesis.

Event Description

Two pericardial tamponades occurred in the pfa group.Of those two pericardial tamponades reported, one was most likely caused by complex tsp and led to surgical treatment.The other pericardial tamponade occurred on the day after pvi and was managed by pericardiocentesis.Both physician authors of the literature article confirmed that neither adverse event were the result of abbott device use or procedure.

Manufacturer Narrative

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 conclusively determined.Both physician authors of the literature article confirmed that neither adverse event were the result of abbott device use or procedure, making this event not reportable.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18187265
• MDR Text Key: 328736787
• Report Number: 3005334138-2023-00535
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention