FDA Adverse Event Injury Summary report: N

TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

MDR report key: 16632185 · Received March 28, 2023

Report

Report Number: 3005334138-2023-00127
Event Type: Injury
Date Received: March 28, 2023
Report Date: March 28, 2023
Manufacturer: ST. JUDE MEDICAL
Product Code: OAE
PMA / PMN Number: P130026
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY (2023) 66:215¿220 IN AN ARTICLE TITLED "LONG-TERM OUTCOME OF VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WHO DID NOT UNDERGO PROGRAMMED ELECTRICAL STIMULATION AFTER ABLATION", TAKESHI KITAMURA, HTTPS://DOI.ORG/10.1007/S10840-021-01037-4. A TOTAL OF 183 ABLATION PROCEDURES IN PATIENTS WITH SHD WHO UNDERWENT CATHETER ABLATION FOR VT BY USING AN IRRIGATED ABLATION CATHETER BETWEEN NOVEMBER 2009 AND DECEMBER 2018 WERE RETROSPECTIVELY SEARCHED. THIS RETROSPECTIVE OBSERVATIONAL ANALYSIS EVALUATED VT ABLATION PROCEDURES IN PATIENTS WITH SHD IN WHOM PES WAS NOT PERFORMED AT THE END OF THE VT ABLATION PROCEDURE. THE REVIEW REVEALED EVENTS OF 2 CARDIAC TAMPONADES, 2 TRANSIENT ATRIOVENTRICULAR BLOCKS, 1 CARDIAC ARREST, AND 1 AIR EMBOLI IN THE RIGHT CORONARY ARTERY OCCURRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421176	TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿	CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION	OAE	ST. JUDE MEDICAL

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Life Threatening