FDA Adverse Event Injury Summary report: N

VENATECH

MDR report key: 6040440 · Received October 19, 2016

Report

Report Number: 9612452-2016-00038
Event Type: Injury
Date Received: October 19, 2016
Date of Event: September 16, 2015
Report Date: November 22, 2017
Manufacturer: B.BRAUN MEDICAL SAS - OWNER
Product Code: DTK
PMA / PMN Number: K010485
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DESPITE MANUFACTURER'S REQUESTS, EITHER THE DEVICE, NOR X-RAY PICTURES WERE FORWARDED FOR EVALUATION. NO INVESTIGATION CAN BE PERFORMED. IF NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE COMPLETED.

Additional Manufacturer Narrative · 1

BATCH HISTORY REVIEW: THE MANUFACTURING FILE OF THIS BATCH OF VENA CAVA FILTERS HAS BEEN REVIEWED. IT COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER INCIDENT HAS BEEN REPORTED ON THE BATCH SOLD SINCE SEPTEMBER 2008. B BRAUN MEDICAL SAS HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION, AT THIS TIME WE HAVE NOT MET WITH SUCCESS. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY B BRAUN MEDICAL SAS, OR ITS EMPLOYEES THAT THE DEVICE, B BRAUN MEDICAL SAS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.

Description of Event or Problem · 1

ON OR ABOUT (B)(6) 2009, PATIENT IMPLANTED WITH A BRAUN VENATECH FILTER. ON (B)(6) 2015, PATIENT UNDERWENT AN IR VENOGRAM WHICH DEMONSTRATED THAT THE VENATECH FILTER WAS SURROUNDED BY THOMBI AND HAD BEEN CRUSHED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
693362	VENATECH	VENA CAVA FILTER SYSTEM	DTK	B.BRAUN MEDICAL SAS - OWNER	5010024	H206857V

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R