FDA Adverse Event Malfunction Summary report: N

PENUMBRA SYSTEM SEPARATOR 032

MDR report key: 1930342 · Received November 18, 2010

Report

Report Number: 3005168196-2010-00691
Event Type: Malfunction
Date Received: November 18, 2010
Date of Event: October 7, 2010
Report Date: October 26, 2010
Manufacturer: PENUMBRA INC.
Product Code: NRY
PMA / PMN Number: K072718
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE INVESTIGATION: THE DISTAL END OF THE BROKEN SEPARATOR WAS RETURNED LODGED IN THE CATHETER. THE SEPARATOR WAS BROKEN AND KINKED APPROX 5.5 CM DISTAL OF THE BEGINNING OF THE GREEN PTFE COATING. THE BULB OF THE SEPARATOR WAS LODGED AGAINST THE PROXIMAL SIDE OF AN OVALIZATION 1.5 CM FROM THE DISTAL TIP OF THE CATHETER. THE DEVICE IS NON FUNCTIONAL. CONCLUSION: ACCORDING TO THE COMPLAINT, THE CATHETER AND SEPARATOR WERE BEING USED TOGETHER SUCCESSFULLY AT THE BEGINNING OF THE PROCEDURE. IT APPEARS THAT THE CATHETER MAY HAVE OVALIZED IN ANATOMY AND THE SEPARATOR WAS CONTINUALLY ADVANCED AGAINST THE RESISTANCE CAUSED BY THE OVALIZATION. CONTINUED MANIPULATION OF THE PROXIMAL PORTION OF THE SEPARATOR RESULTED IN THE KINKING AND EVENTUAL BREAKAGE OF THE SEPARATOR WIRE.

Description of Event or Problem · 1

THE PHYSICIAN WAS USING THE SEPARATOR TO CLEAR THE TIP OF THE CATHETER DURING STROKE TREATMENT. HE SUDDENLY NOTICED THE SEPARATOR HAD BROKEN INSIDE THE CATHETER. HE WAS ABLE TO CAREFULLY REMOVE THE CATHETER AND SEPARATOR GETTING BOTH DEVICES OUT OF THE PT. HE COMPLETED THE CASE WITH A SECOND CATHETER AND SEPARATOR. THE PT WAS NOT AFFECTED BY THE DEVICE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PENUMBRA SYSTEM SEPARATOR 032	PERCUTANEOUS CATHETER	NRY	PENUMBRA INC.		F17190

Patients

Seq	Age	Sex	Outcome	Treatment
1