THERAPY ABLATION CATHETER

Report

Report Number: 2030404-2010-00012
Event Type: Injury
Date Received: May 12, 2010
Date of Event: March 18, 2010
Report Date: April 13, 2010
Manufacturer: IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
Product Code: LPB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE CATHETER WAS DISCARDED AFTER THE PROCEDURE. THE LOT NUMBER WAS NOT AVAILABLE TO REVIEW THE DEVICE HISTORY RECORD. OTHER DEVICES WERE USED IN THE CASE. THE CAUSE FOR THE REPORTED PERFORATION IS UNKNOWN. THE DESIGN HAS BEEN VALIDATED TO MEET THE BUCKLING LOAD REQUIREMENT (SIMULATION OF FORCE REQUIRED TO PERFORATE TISSUE). CATHETERS ARE 100% INSPECTED IN-PROCESS AND AT FINAL INSPECTION FOR ELECTRICAL AND MECHANICAL INTEGRITY TO ENSURE THEY MEET THE SPECIFICATIONS REQUIREMENTS. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), VASCULAR PERFORATION IS AN INHERENT RISK AND THAT THE CATHETER SHOULDN'T BE FORCED INTO THE VESSEL.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERFORATION OCCURRED DURING AN AF ABLATION PROCEDURE. THIS WAS THE FIRST TIME THE COOL PATH CATHETER WAS USED IN CONJUNCTION WITH AN AGILIS NXT SHEATH. WHILE (B) (6) WAS APPLYING RF, (B) (6) REALIZED THE PATIENT WAS TURNING HYPOTONIC. QUICKLY THEY SAW ECO IMAGE THAT THE PATIENT WAS TAMPONADED. THEY HAD TO EXTRACT LIQUID FROM THE HEMORRHAGE, AND THE PATIENT NEEDED A BLOOD PERFUSION. THE PATIENT WAS IN OBSERVATION A FEW DAYS UNTIL HE RECOVERED. (B) (6) IS UNSURE IF THE PROBLEM WAS BECAUSE OF THE CATHETER, THE AGILIS OR THE COMBINATION OF BOTH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THERAPY ABLATION CATHETER	CARDIAC PERCUTANEOUS ABLATION CATHETER	LPB	IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY	83352	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	AGILIS NXT\| 1500T11 GENERATOR