FDA Adverse Event Injury Summary report: N

HALO90 ABLATION CATHETER

MDR report key: 2885024 · Received December 18, 2012

Report

Report Number: 3004904811-2012-00155
Event Type: Injury
Date Received: December 18, 2012
Date of Event: December 18, 2011
Report Date: November 19, 2012
Manufacturer: COVIDIEN/BARRX
Product Code: GEI
PMA / PMN Number: K093008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS SITE DID NOT RETURN ANY DEVICE, THEREFORE AN ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFO PERTINENT TO THIS EVENT BE OBTAINED, A F/U REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem · 1

COVIDIEN LEARNED ON (B)(6) 2012 THAT A PT WITH BARRETT'S ESOPHAGUS WITH DYSPLASIA HAD BEEN TREATED UNEVENTFULLY WITH FOCAL RFA ON (B)(6) 2011. NINE DAYS LATER, THE PT PRESENTED TO THE HOSPITAL FEELING UNWELL. IMMEDIATELY UPON LEARNING OF THIS EVENT, COVIDIEN MEDICAL STAFF CONTACTED THE TREATING GASTROENTEROLOGIST AND WAS INFORMED THAT THE EMERGENCY ROOM STAFF SUSPECTED CARDIOGENIC AND SEPTIC PROCESSES DUE TO PRESENTING SEVERE HYPOTENSION, UNTIL THE PT VOMITED BLOOD. THE PT THEN UNDERWENT UPPER ENDOSCOPY WHICH CONFIRMED BLOOD IN THE STOMACH. BLOOD LOSS FROM THE ABLATION ZONE WAS THE PRESUMED SOURCE OF BLEEDING. BEFORE SENIOR GASTROENTEROLOGY STAFF WAS CONTACTED TO PERFORM UPPER ENDOSCOPY WITH ENDOSCOPIC EVACUATION OF THE CLOT AND ENDOSCOPIC CONTROL OF BLEEDING (NON-SURGICAL), A SURGICAL CONSULTATION WAS OBTAINED, THE PT TAKEN TO THE OPERATING ROOM, AND THORACOTOMY WITH EXTERNAL CONTROL OF BLEEDING WAS PERFORMED. THIS RESULTED IN THE NECESSITY OF AN IVOR-LEWIS PARTIAL ESOPHAGECTOMY. THE PT HAS SINCE RECOVERED WITH NO FURTHER RFA RELATED MORBIDITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HALO90 ABLATION CATHETER	ELECTROSURGICAL COAGULATION SYSTEM	GEI	COVIDIEN/BARRX		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| R