FDA Adverse Event Malfunction Summary report: N

PENUMBRA SYSTEM SEPARATOR 032

MDR report key: 1963562 · Received December 20, 2010

Report

Report Number: 3005168196-2010-00708
Event Type: Malfunction
Date Received: December 20, 2010
Date of Event: December 1, 2010
Report Date: December 2, 2010
Manufacturer: PENUMBRA, INC.
Product Code: NRY
PMA / PMN Number: K072718
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE INVESTIGATION: THE SEPARATOR SHOWS A SLIGHT HOOK IN THE DISTAL TIP. IN ADDITION, THERE ARE A NUMBER OF GENTLE BENDS OR WAVES IN THE MOST DISTAL 15 CM OF THE SEPARATOR WIRE. THERE IS AN ANGLE OF APPROX 25 DEGREES 25 CM FROM THE DISTAL TIP. THE SEPARATOR WAS INTRODUCED INTO AN EXEMPLAR (B)(4) AND ADVANCED. IT PROVED DIFFICULT TO INTRODUCE THE BULB OF THE SEPARATOR WITHOUT GETTING THE "HOOK" FOLDED DOUBLE. THE SEPARATOR ADVANCED APPROX 90 CM BEFORE THE BENT TIP JAMMED AGAINST THE SIDE AND STOPPED THE FORWARD MOTION. THE SEPARATOR IS NON FUNCTIONAL. CONCLUSION: THE BEND LOCATION MENTIONED IN THE COMPLAINT WAS NOT CONFIRMED. THE BENDS SEEN ARE TYPICAL OF HANDLING DAMAGE THAT MAY OR MAY NOT HAVE INCLUDED USE OF THE DEVICE. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

Description of Event or Problem · 1

A REPERFUSION CATHETER 032 HAD A CRACKED SEGMENT IN IT DISTAL TO THE HUB IN THE MAIN BODY OF THE CATHETER WHICH LENT ITSELF TO INADEQUATE ASPIRATION. IN ADDITION, THE 032 SEPARATOR HAD A 45 DEGREE BEND IN THE WIRE ABOUT 10 CM PROXIMAL TO THE DISTAL TIP WHEN IT WAS PULLED OUT OF THE LOOP. THIS MDR IS ASSOCIATED WITH 3005168196-2010-00707.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PENUMBRA SYSTEM SEPARATOR 032	PERCUTANEOUS CATHETER	NRY	PENUMBRA, INC.		F13538

Patients

Seq	Age	Sex	Outcome	Treatment
1