FDA Adverse Event Malfunction Summary report: N

PENUMBRA SYSTEM REPERFUSION CATHETER 032

MDR report key: 2882838 · Received December 20, 2012

Report

Report Number: 3005168196-2012-00438
Event Type: Malfunction
Date Received: December 20, 2012
Date of Event: November 20, 2012
Report Date: November 21, 2012
Manufacturer: PENUMBRA, INC.
Product Code: NRY
PMA / PMN Number: K072718
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE INVESTIGATION: RESULTS: THERE ARE TWO FLAT SPOTS IN THE CATHETER AT 3.7 AND 3.0 CM FROM THE DISTAL TIP. A 0.032" MANDREL WAS INTRODUCED INTO THE HUB OF THE CATHETER AND ADVANCED DISTALLY. PROGRESS OF THE MANDREL THROUGH THE CATHETER WAS SMOOTH UNTIL THE TIP OF THE MANDREL REACHED THE FLAT SPOT AT 3.7 CM FROM THE DISTAL TIP. AT THIS POINT FRICTION INCREASED DRAMATICALLY AND FORWARD MOVEMENT STOPPED. THIS CATHETER IS NON- FUNCTIONAL. CONCLUSION: THE "FOLD" NEAR THE DISTAL TIP NOTED IN THE COMPLAINT ARE CONFIRMED. THE CAUSE OF THE "FOLD" CANNOT BE DIRECTLY DETERMINED BUT THIS SECTION OF THE CATHETER IS DELICATE AND IS SUSCEPTIBLE TO HANDLING DAMAGE IF IT IS INCAUTIOUSLY MANIPULATED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

Description of Event or Problem · 1

ON (B)(6) 2012, THE PHYSICIAN PERFORMED THROMBECTOMY ON THE PATIENT WITH CEREBRAL INFARCTION. THE PHYSICIAN ATTEMPTED TO HAVE THE PSC032 ADVANCED ALONG A MICRO GUIDE WIRE BUT IT WENT STUCK NEAR THE DISTAL TIP AND DID NOT ENTER THE SHEATH. AFTERWARDS, IT WAS FOUND THAT THE PSC032 WAS FOLDED UP NEAR THE DISTAL TIP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PENUMBRA SYSTEM REPERFUSION CATHETER 032	NRY	NRY	PENUMBRA, INC.		F26330

Patients

Seq	Age	Sex	Outcome	Treatment
1