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

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

Patient Problems Nerve Damage (1979); Transient Ischemic Attack (2109); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

Concomitant device: swartz¿ introducer, unknown.

Event Description

Related manufacturer report number: 3005334138-2023-00423.The following was published in hellenic journal of cardiology 72 : 15-23.Hellenic cardiological society.(jul 1, 2023) "an evaluation of the clinical efficacy of the application of 28mm cryoballoon for linear ablation of left atrial apex combined with enlarged pulmonary vein vestibule ablation for persistent atrial fibrillation"; lin, ya-zhou.A total of 413 patients with persistent atrial fibrillation were treated with 28-mm cryoballoon ablation.Baseline clinical data of the patients, including demographic characteristics, comorbidities, personal history, laboratory tests, cardiac function, and af characteristics, are shown in table 1.230 of the 413 patients underwent pvi only, and 183 underwent pvi plus pulmonary vein vestibule enlargement ablation and left atrial apical ablation.The median duration of atrial fibrillation was 24 months.The left pulmonary vein was co-interrupted in 11 cases.Patients in the pviplus group had a higher incidence of stroke, better cardiac function and lower bnp levels compared with patients in the pvi group.The differences in other data were not statistically significant.One patient experienced a postoperative transient ischemic attack (tia) during hospitalization that resolved within 24 hours.There was nothing during the procedure that was unexpected.There are no reported performance issues with any abbott device.The patient has no known history of cvas.A transesophageal echocardiogram was done prior to the procedure to rule out thrombosis.Heparin was used during the procedure.Act levels assessed - 10 minutes.The patient has recovered.There are no reported performance issues with any abbott device.One patient had a drop in blood pressure and an intraoperative pericardial tamponade was diagnosed by ultrasound and fluoroscopy.A pericardiocentesis was performed to resolve the issue and stabilize the patient.Additionally, rapid right ventricular pacing (120 beats/min) was done for several minutes, and the ablation procedure was then continued and successfully completed.Heparin was used during the procedure.There are no reported performance issues with any abbott device.Seven cases of phrenic nerve injury were observed, which showed reduced phrenic nerve pacing signal and diaphragm elevation.Six of the 7 pni cases occurred during freezing of the right upper pulmonary vein and 1 during freezing of the right lower pulmonary vein.Medication was administered to treat and the patients recovered.There are no reported performance issues with any abbott device.

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 conclusively determined.

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 incident could not be conclusively determined.

Event Description

Updated report needed to correct analysis verbiage to include the device history record was not possible as the lot number is unknown.

• Brand Name: THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER
• 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: 17778276
• MDR Text Key: 323788258
• Report Number: 2030404-2023-00060
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• 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: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention