FDA Adverse Event Malfunction Summary report: N

INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER

MDR report key: 3833910 · Received May 27, 2014

Report

Report Number: 2134265-2014-02826
Event Type: Malfunction
Date Received: May 27, 2014
Report Date: April 28, 2014
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Product Code: OAD
PMA / PMN Number: P020025
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVENT DATE: (B)(4) 2014. PATIENT AGE: OVER 18 YEARS OLD. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS A KINK AT THE DISTAL SECTION AND THE ADHESIVE OF THE SECOND RING LIFT AND BROKEN, AND THERE IS BLOOD UNDER THE ADHESIVE. NO OTHER VISUAL DEFECTS WERE FOUND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

REPORTABLE UPON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, NOISE WAS EXPERIENCED. THE TARGET LESION WAS LOCATED IN THE RIGHT ATRIAL CAVO TRICUSPID ISTHMUS. AN INTELLATIP MIFI TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. DURING ABLATION A NOISY ELECTROGRAM AND POOR SIGNALS OCCURRED. THE PHYSICIAN SWITCHED TO A NON-BSC DEVICE WHICH ALSO DELIVERED POOR SIGNALS AND COMPLETED THE PROCEDURE WITH A BLAZER ABLATION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. DEVICE ANALYSIS FOUND A LIFTED ELECTRODE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310896	INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER	CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER	OAD	BOSTON SCIENTIFIC - COSTA RICA (COYOL)	M004PM4500K20	16460273

Patients

Seq	Age	Sex	Outcome	Treatment
1