FDA Adverse Event Malfunction Summary report: N

NEURON DELIVERY CATHETER 070

MDR report key: 1830818 · Received March 15, 2010

Report

Report Number: 3005168196-2010-00264
Event Type: Malfunction
Date Received: March 15, 2010
Date of Event: December 17, 2008
Report Date: December 17, 2008
Manufacturer: PENUMBRA, INC.
Product Code: DQY
PMA / PMN Number: K082290
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

TECHNICAL EVALUATION: THE DEVICE SHOWED A KINK AT 2.5CM FROM THE TIP. THE KINK COLLAPSED THE FLEXIBLE TUBE WALL AND REDUCED THE INNER DIAMETER. CONCLUSION: THE DAMAGE TO THE DISTAL SECTION MAY HAVE OCCURRED IN TRANSIT TO/FROM PENUMBRA TO THE CUSTOMER OR MAY HAVE BEEN DAMAGED DURING THE PACKAGING PROCESS AT PENUMBRA. A DHR REVIEW WAS CONDUCTED OF THE LOT AND THE REPORT IS ATTACHED. 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 # 1626-04 NEURON DELIVERY CATHETER 070 (95CM X 6 CM) SHAPED TIP, LOT NUMBER L13773. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L13773) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS. (B)(4). 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 RELEASE MET SPECIFICATIONS. NO OTHER ANOMALIES WERE FOUND WITH THIS LOT DUE TO THE MANUFACTURING PROCESS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

Description of Event or Problem · 1

THE DEVICE WAS DAMAGED DURING TRANSIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEURON DELIVERY CATHETER 070	PERCUTANEOUS CATHETER	DQY	PENUMBRA, INC.		F13773

Patients

Seq	Age	Sex	Outcome	Treatment
1