FDA Adverse Event Injury Summary report: N

COOL PATH¿ IRRIGATED ABLATION CATHETER

MDR report key: 15668409 · Received October 25, 2022

Report

Report Number: 2030404-2022-00064
Event Type: Injury
Date Received: October 25, 2022
Report Date: December 18, 2022
Manufacturer: ST. JUDE MEDICAL
Product Code: OAD
PMA / PMN Number: P060019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TW
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. 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. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

Description of Event or Problem · 0

THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY (2022) 64:587¿59. "THE IMPACT OF HEIGHT ON RECURRENCE AFTER INDEX CATHETER ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION", DR. CHING-HAN LIU,. RECEIVED: 11 MAY 2021 / ACCEPTED: 18 AUGUST 2021 / PUBLISHED ONLINE: 1 SEPTEMBER 2021. IN THIS STUDY, WE RETROSPECTIVELY ENROLLED 689 PATIENTS (470 MEN; AGE, 53.0±11.7 YEARS) WITH SYMPTOMATIC AND DRUG REFRACTORY PAF WHO UNDERWENT FRST-TIME ELECTROPHYSIOLOGY STUDY AND CA BETWEEN 2003 AND 2013. THIS STUDY WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD OF TAIPEI VETERANS GENERAL HOSPITAL (IRB-TPEVGH NO. 201. NINE PATIENTS EXPERIENCED PERIPROCEDURAL PERICARDIAL EFFUSIONS THAT DID NOT REQUIRE PERICARDIOCENTESIS. THERE WERE THREE CASES OF CARDIAC TAMPONADE REQUIRING IMMEDIATE PERICARDIOCENTESIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2573668	COOL PATH¿ IRRIGATED ABLATION CATHETER	CARDIAC ABLATION PERCUTANEOUS CATHETER	OAD	ST. JUDE MEDICAL

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention