ACHIEVE MAPPING CATHETER

MDR report key: 2892107 · Received January 2, 2013

Report

Report Number: 3007798852-2013-00001
Event Type: Injury
Date Received: January 2, 2013
Date of Event: December 3, 2012
Report Date: December 3, 2012
Manufacturer: MEDTRONIC ABLATION FRONTIERS
Product Code: DRF
PMA / PMN Number: K102588
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

AFTER TRANSSEPTAL PUNCTURE, THE SHEATH WAS BROUGHT INTO THE LEFT SIDE OF THE HEART. THE CRYOABLATION CATHETER AND MAPPING CATHETER WERE INSERTED THROUGH THE SHEATH, AND THE CRYOBALLOON WAS INFLATED. WHEN CONTRAST WAS INJECTED, ANATOMY DID NOT LOOK LIKE VEIN. THE CRYOBALLOON WAS DEFLATED, CATHETERS REPOSITIONED INTO LSPV, AND CRYOBALLOON WAS REINFLATED. CONTRAST WAS INJECTED AND IDENTIFIED A GOOD BALLOON OCCLUSION. AS CRYO APPLICATION STARTED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. UTILIZING ICE, THE PHYSICIAN IDENTIFIED PERFORATION IN VENTRICLE. ABLATION WAS STOPPED AT 237 SECONDS AT -57 DEGREES. PHYSICIANS UTILIZED PERICARDIOCENTISIS KIT AND REMOVED FLUID AND PATIENT WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1852	ACHIEVE MAPPING CATHETER	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING	DRF	MEDTRONIC ABLATION FRONTIERS	990063-020

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention	ARCTIC FRONT ADVANCE (B)(4), FLEXCATH SHEATH 3FC12