FDA Adverse Event Injury Summary report: N

FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿

MDR report key: 9097459 · Received September 20, 2019

Report

Report Number: 3005334138-2019-00528
Event Type: Injury
Date Received: September 20, 2019
Date of Event: July 16, 2019
Report Date: October 3, 2019
Manufacturer: ST. JUDE MEDICAL
Product Code: OAD
PMA / PMN Number: P110016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

Additional Manufacturer Narrative · 1

THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

Description of Event or Problem · 1

A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

Description of Event or Problem · 1

RELATED MANUFACTURING REFERENCE: 3005334138-2019-00527, 2030404-2019-00095, 2030404-2019-00096, 2030404-2019-00097. FOLLOWING AN ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. TWO HOURS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED SLIGHT DIZZINESS. ECHOCARDIOGRAPHY DIAGNOSED AN EFFUSION APPROXIMATELY 15 MM CIRCULAR IN THE FRONT OF THE RIGHT ATRIUM AND RIGHT VENTRICLE. A PERICARDIAL EFFUSION WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
894550	FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿	CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER	OAD	ST. JUDE MEDICAL	A-FASE-F

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention