FDA Adverse Event Injury Summary report: N

NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER

MDR report key: 1843058 · Received September 23, 2010

Report

Report Number: 2029046-2010-00054
Event Type: Injury
Date Received: September 23, 2010
Date of Event: August 27, 2010
Report Date: August 27, 2010
Manufacturer: BIOSENSE WEBSTER, INC (IRWINDALE)
Product Code: LPB
PMA / PMN Number: P990025/S9
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON FOLLOW-UP WITH THE CLINICAL ACCOUNT SPECIALIST AND THE LAB MANAGER AT THE FACILITY, THE PATIENT WAS RELEASED A FEW DAYS LATER BUT THE LAB CANNOT PROVIDE ANY SPECIFIC DETAILS ABOUT THE RELEASE DATE, AGE OR GENDER OF THE PATIENT. THE FACILITY WILL NOT BE RETURNING THE DISPOSABLE PRODUCTS FOR ANALYSIS. THE CUSTOMER INDICATED THAT THE BWI EQUIPMENT DID NOT MALFUNCTION, AND THERE IS NO SERVICE REQUIRED. SHOULD THE PRODUCT BE RETURNED TO BWI IN THE FUTURE, AN ANALYSIS WILL BE PERFORMED AND A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: CARTO, RMT V8 SYSTEM, US CATALOG # M550000, (B)(4). STOCKERT 70 RF GENERATOR, US CATALOG # S7001, (B)(4). (B)(4).

Description of Event or Problem · 1

DURING AN IDIOPATHIC VT ABLATION, IT WAS REPORTED THAT A PERFORATION OF THE RIGHT VENTRICULAR OUTFLOW TRACT HAD OCCURRED. THE PROCEDURE WAS STOPPED AND AN ULTRASOUND WAS PERFORMED. THE PATIENT IS CURRENTLY BEING MONITORED. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE IS NO INDICATION THAT ANY BWI EQUIPMENT WAS AT FAULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER	ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION	LPB	BIOSENSE WEBSTER, INC (IRWINDALE)	D-1257-02-S	15158203A

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| O