MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Related manufacturing ref: 3005334138-2022-00455.The following was published in the journal of interventional cardiac electrophysiology 64.1: 67-76.Springer.(jun 2022) "rates of atrial futter occurrence and cavotricuspid isthmus reconduction after prophylactic isthmus ablation performed during atrial fibrillation ablation: a clinical study, review, and comparison with previous findings," dr.Yamaji, hirosuke.Based on the high rate of coexisting atrial fibrillation (af) and atrial flutter (afl), prophylactic cavotricuspid isthmus ablation (ctia) adjunctive to af ablation has recently been attempted in patients with af and without afl.The present study aimed to determine the rates of afl occurrence and cti reconduction after performing cti ablation adjunctive to af ablation.Methods: we analyzed the data of 3833 consecutive patients with af, who underwent prophylactic ctia with af ablation between 2009 and 2020.The present retrospective study found acceptably low rates of clinical afl occurrence and cti reconduction following prophylactic ctia performed with af ablation, which was supported by the findings obtained after performing a comparison of the rates with those of other ablations (af ablation only and ctia for pure afl).Considering the high correlation between af and afl, the present study provided information regarding the efcacy of adjunctive ctia.Periprocedural complications occurred, including cardiac tamponade requiring drainage or cardiocentesis occurred in 15 patients.Inguinal hematoma requiring surgical repair was observed in three patients.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported cardiac tamponade and inguinal hematoma remain unknown.

• Brand Name: THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15192249
• MDR Text Key: 297523740
• Report Number: 2030404-2022-00055
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110016
• 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,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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: 08/12/2022
• 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