MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER; IRRIGATED ABLATION CATHETER

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

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

During the review of the discharge summary received for the (b)(6) 2022 hospitalization, it is observed that the patient developed a mild trop leak, a transesophageal echocardiogram showed revealed a pericardial effusion.Pericarditis was suspected post procedure; added po colchicine x 10 days.The patient has persistent atrial fibrillation and tachycardia bradycardia.Difficult to control arrhythmia with side effects from medications.Benefits, risks, and alternatives to av node ablation and pacing discussed with she and her family.She was brought to the ep lab in stable condition.The right femoral region was prepped and draped in sterile fashion.Under ultrasound guidance, vascular access was achieved 1 time and 8 french sheath was placed.Perclose sutures were placed for pre closed.This access was sequentially up sized until the abbott 25 french sheath was placed in the right atrium over a stiff guidewire.The lead less pacing system was advanced into the right ventricle under fluoroscopic guidance.Right ventricular ventriculography was performed in the rao and lao view to confirm septal position.The device was positioned without complication.Stable pace and sense thresholds were obtained.The delivery system was removed.A 4 mm sapphire ablation catheter was advanced and rf was applied on the his bundle until third-degree av block was achieved.The catheter and sheath removed and hemostasis was achieved using perclose x2.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the dhr was not possible as the lot number is unknown.Based on the information received, the cause of the reported perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Type of Device: IRRIGATED ABLATION CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15716943
• MDR Text Key: 302881595
• Report Number: 2182269-2022-00052
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960016
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female