FDA Adverse Event Malfunction Summary report: N

NEURON DELIVERY CATHETER 070

MDR report key: 1934233 · Received December 8, 2010

Report

Report Number: 3005168196-2010-00694
Event Type: Malfunction
Date Received: December 8, 2010
Report Date: November 10, 2010
Manufacturer: PENUMBRA INC.
Product Code: DQY
PMA / PMN Number: K082290
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE INVESTIGATION: THE CATHETER IS BROKEN AT THE BEGINNING OF THE STRAIN RELIEF SPIRAL CUT APPROX 3.0 CM FROM THE HUB-SHAFT JOINT. THE TWO PIECES ARE CONNECTED BY THE STRUCTURAL WIRES. THE CATHETER IS NON FUNCTIONAL. CONCLUSION: THE COMPLAINT AND SUBSEQUENT COMMUNICATIONS WITH THE PHYSICIAN INDICATE THAT THE BREAK WAS FIRST NOTICED AS A LEAK AFTER THE NEURON WAS ATTACHED TO THE RHV ONCE THE DELIVERY CATHETER WAS IN POSITION IN ANATOMY. IT IS UNCLEAR WHETHER THE BREAK WAS PRESENT OUT OF BOX OR IF IT WAS THE RESULT OF HANDLING WHEN POSITIONING IN THE PT. THE COMPLETE SEPARATION AND UNWRAPPING OF THE SUPPORT WIRE LIKELY HAPPENED WHEN THE CATHETER WAS REMOVED OR AS A RESULT OF POST-EVENT HANDLING.

Description of Event or Problem · 1

THE PHYSICIAN USED A DIAGNOSTIC CATHETER AS A GUIDE CATHETER COAXIALLY WITH A NEURON DELIVERY CATHETER. THE PHYSICIAN DID NOT USE THE PEEL AWAY SHEATH PROVIDED WITH THE NEURON. AFTER THE PHYSICIAN PLACED THE NEURON, HE REMOVED THE DIAGNOSTIC CATHETER AND ATTACHED THE NEURON TO THE RHV. WHEN THE PHYSICIAN STARTED FLUSHING, HE NOTICED A LEAK AND THEN A BREAK IN THE PROXIMAL AREA OF THE NEURON. THE PHYSICIAN USED A NEW NEURON WITH THE DIAGNOSTIC CATHETER AND THE PROCEDURE WAS SUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEURON DELIVERY CATHETER 070	PERCUTANEOUS CATHETER	DQY	PENUMBRA INC.		F16628

Patients

Seq	Age	Sex	Outcome	Treatment
1