FDA Adverse Event Malfunction Summary report: N

G2 FILTER SYSTEM - FEMORAL

MDR report key: 1815844 · Received August 19, 2010

Report

Report Number: 2020394-2010-00256
Event Type: Malfunction
Date Received: August 19, 2010
Date of Event: July 21, 2010
Report Date: July 28, 2010
Manufacturer: BARD PERIPHERAL VASCULAR, INC.
Product Code: DTK
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND IN THE RECORDS TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K) - K062887.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL, THE FILTER COULD NOT BE RETRIEVED AS IT WAS TILTED, WITH ONE FILTER LEG EXTENDING OUTSIDE THE CONTRAST COLUMN AND THE FILTER APEX APPEARED TO BE EMBEDDED IN THE CAVA WALL. THE FILTER WAS IMPLANTED SEVEN MONTHS AGO IN A MALE TRAUMA PATIENT. DURING THE RETRIEVAL ATTEMPT, A RECOVERY CONE WAS ADVANCED BUT THE FILTER APEX COULD NOT BE CAPTURED. THIS CONE WAS REMOVED AND REPLACED, AS IT WAS REPORTED THAT THE MEMBRANE BECAME TORN. ANOTHER CONE WAS ADVANCED, BUT THE APEX STILL COULD NOT BE CAPTURED. THE FILTER REMAINS IMPLANTED WHILE THE PHYSICIANS DETERMINE THE COURSE OF ACTION, IF ANY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	G2 FILTER SYSTEM - FEMORAL		DTK	BARD PERIPHERAL VASCULAR, INC.		GFTG2272

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR