FDA Adverse Event Malfunction Summary report: N

NEURON DELIVERY CATHETER 070

MDR report key: 1833913 · Received March 15, 2010

Report

Report Number: 3005168196-2010-00242
Event Type: Malfunction
Date Received: March 15, 2010
Date of Event: November 4, 2008
Report Date: November 4, 2008
Manufacturer: PENUMBRA, INC.
Product Code: DQY
PMA / PMN Number: K082290
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS RETURNED BUT NO INVESTIGATION TOOK PLACE BECAUSE THE CATHETERS WERE SEVERELY DAMAGED IN TRANSIT BACK TO PENUMBRA. NO CONCLUSIONS COULD BE DRAWN. THE DHRS OF THESE MANUFACTURING LOTS HAVE BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 16260-03/A, (LOT # L13971). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT # L13971) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) VISUAL REJECTS. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENTS.

Description of Event or Problem · 1

THE NEURON TIPS WERE FOUND FLATTENED WHEN THE BOXES WERE OPENED FOR INSPECTION. THE DELIVERY BOX HAD BEEN CRUSHED IN TRANSPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEURON DELIVERY CATHETER 070	PERCUTANEOUS CATHETER	DQY	PENUMBRA, INC.		F13971

Patients

Seq	Age	Sex	Outcome	Treatment
1