FDA Adverse Event Injury Summary report: N

TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER

MDR report key: 8566720 · Received April 30, 2019

Report

Report Number: 9680001-2019-00073
Event Type: Injury
Date Received: April 30, 2019
Report Date: April 30, 2019
Manufacturer: VENUSA DE MEXICO S.A. DE C.V.
Product Code: OAE
PMA / PMN Number: P130026
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT DEVICES: COOL FLEX CATHETER, FLEXABILITY CATHETER, EVENT DATE UNKNOWN. THE REPORTED EVENT OF PROCEDURAL COMPLICATION COULD NOT BE CONFIRMED. 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.

Description of Event or Problem · 1

RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2019-00032, 3005334138-2019-00247. THE FOLLOWING WAS PUBLISHED IN THE JAPANESE CIRCULATION SOCIETY TITLED, "TRENDS AND OUTCOME OF CATHETER ABLATION OF ATRIAL FIBRILLATION OVER 9 YEARS - FOCUS ON EMPIRICAL EXTRA-PULMONARY VEIN ABLATION" BY JE-WOOK PARK, ET AL. THE BASELINE CHARACTERISTICS OF 2,297 ENROLLED PATIENTS WHO UNDERWENT ABLATIONS BETWEEN 2009 AND 2017 ARE LISTED IN TABLE 1. PATIENT AGE, THE PROPORTION OF FEMALE PATIENTS, AND CHA(2)DS(2)VASC SCORE GRADUALLY INCREASED OVER THE 9 YEARS. THE PROPORTION OF PATIENT WITH CONGESTIVE HEART FAILURE ALSO INCREASED. WITH MESH-TYPE FLEXIBLE TIP (MFT) CATHETERS, 44 PATIENTS HAD COMPLICATIONS (24 MAJOR COMPLICATIONS).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
359114	TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER	CARDIAC ABLATION PERCUTANEOUS CATHETER	OAE	VENUSA DE MEXICO S.A. DE C.V.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other