FDA Adverse Event Injury Summary report: N

NRG TRANSSEPTAL NEEDLE

MDR report key: 5150183 · Received October 14, 2015

Report

Report Number: 9710452-2015-00019
Event Type: Injury
Date Received: October 14, 2015
Report Date: October 14, 2015
Manufacturer: BAYLIS MEDICAL COMPANY INC.
Product Code: DXF
PMA / PMN Number: K073326
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THERE IS NO SUSPECTED DEVICE FAILURE. PERFORATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE AND IS IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE.

Description of Event or Problem · 1

DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, BAYLIS MEDICAL DEVICES WERE IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: HSU, J. C., BADHWAR, N., GERSTENFELD, E. P., LEE, R. J., MANDYAM, M. C., DEWLAND, T. A., KOURTNEY, E.I., KURT, S.H., VASANTH, V., BYRON K.L., ZIAN H.T., MELVIN M.S., JEFFREY, E.O., AND MARCUS, G. M. (2013). RANDOMIZED TRIAL OF CONVENTIONAL TRANSSEPTAL NEEDLE VERSUS RADIOFREQUENCY ENERGY NEEDLE PUNCTURE FOR LEFT ATRIAL ACCESS (THE TRAVERSE LA STUDY). JOURNAL OF THE AMERICAN HEART ASSOCIATION, 2(5), E000428. AS PER THIS ARTICLE, "IN THE RF NEEDLE ARM, 1 PATIENT WAS FOUND TO HAVE A PERICARDIAL EFFUSION DETECTED BY ICE AFTER CONCLUSION OF THE LA ABLATION PROCEDURE (3 HOURS AFTER THE TRANSSEPTAL PUNCTURE)."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
679079	NRG TRANSSEPTAL NEEDLE	RF TRANSSEPTAL NEEDLE	DXF	BAYLIS MEDICAL COMPANY INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other