FDA Adverse Event Malfunction Summary report: N

15CM PERCUTANEOUS ANTENNA X1

MDR report key: 5385306 · Received January 22, 2016

Report

Report Number: 3006451981-2016-00030
Event Type: Malfunction
Date Received: January 22, 2016
Date of Event: October 9, 2015
Report Date: October 12, 2015
Manufacturer: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
Product Code: NEY
UDI-DI: 10884521189539
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).THIS COMPLAINT IS PART OF A RETROSPECTIVE REVIEW AS PART OF A REMEDIATION RELATED TO CAPA2015-009106. COVIDIEN¿S INVESTIGATION IDENTIFIED TWO POSSIBLE ROOT CAUSES FOR THE DEVICE FAILURE. THE HUB DIVIDER SHIFTING DISTALLY WITHIN THE HUB OR THE INFLOW TUBE EXPANDING OR RUPTURING. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. A SPACER WAS ADDED TO PREVENT THE HUB FROM SHIFTING. ADDITIONALLY, THE INFLOW TUBE MATERIAL WAS REVISED. THE NEW INFLOW TUBE IS MADE FROM POLYIMIDE, WHICH RESULTS IN INFLOW TUBES WITH MORE STRENGTH REDUCING THE LIKELIHOOD OF EXPANSION OR RUPTURE

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT DURING A LIVER ABLATION CASE THIS PARTICULAR ANTENNA WAS GOING TO BE USED FOR 3 ABLATIONS AROUND THE SAME LESION. JUST PRIOR TO 3RD ACTIVATION REP NOTICED THAT THE SALINE FLOW HAD SLOWED TO A DRIP. SINCE THE ANTENNA HAD ALREADY BEEN POSITIONED FOR 3RD ABLATION THE ENERGY WAS ACTIVATED. AFTER 2 SECONDS A HIGH TEMP CONDITION DISCONTINUED THE ENERGY. THE ANTENNA WAS REMOVED AND A 2ND ANTENNA OF THE SAME LOT WAS OPENED AND INSERTED TO COMPLETE THE 3RD ABLATION. THE 3RD ABLATION WAS COMPETED WITH NO FURTHER ISSUES. THERE WERE NO NOTICEABLE LINE OBSTRUCTIONS, LEAKS OR KINKS IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
44706	15CM PERCUTANEOUS ANTENNA X1	15CM PERCUTANEOUS ANTENNA X1	NEY	COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN	CA15L1	S5FG007X	10884521189539

Patients

Seq	Age	Sex	Outcome	Treatment
1