FDA Adverse Event Malfunction Summary report: N

NEURON DELIVERY CATHETER 070

MDR report key: 1589067 · Received January 19, 2010

Report

Report Number: 3005168196-2010-00051
Event Type: Malfunction
Date Received: January 19, 2010
Date of Event: April 9, 2009
Report Date: April 9, 2009
Manufacturer: PENUMBRA, INC.
Product Code: DQY
PMA / PMN Number: K082290
Removal / Correction Number: Z-0001-2010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

TECHNICAL EVALUATION: THE NEURON HAD A SEPARATION HELD IN PLACE BY THE COIL WIRE 21.5CM FROM THE DISTAL TIP. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN IN RESPONSE TO THE 483 ISSUED TO PENUMBRA ON AUGUST 28, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1626-02.B, (LOT # L14102). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L14102) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS FOR VISUAL AND DIMENSIONAL MEASUREMENT. ALL PARTS THAT FAILED INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. (B)(4).

Description of Event or Problem · 1

THE NEURON 070 BROKE PROXIMAL TO THE DISTAL TRANSITION AND WAS HELD TOGETHER BY THE BRAID REINFORCEMENT. THE NEURON WAS REMOVED FROM THE BODY. THERE WAS NO PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEURON DELIVERY CATHETER 070	PERCUTANEOUS CATHETER	DQY	PENUMBRA, INC.		F14102

Patients

Seq	Age	Sex	Outcome	Treatment
1