PENUMBRA SYSTEM MAX ASPIRATION TUBING

MDR report key: 4867065 · Received June 24, 2015

Report

Report Number: 3005168196-2015-00640
Event Type: Malfunction
Date Received: June 24, 2015
Date of Event: June 1, 2015
Report Date: June 1, 2015
Manufacturer: PENUMBRA, INC.
Product Code: NRY
PMA / PMN Number: K151623
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PROCODE: NRY, NRY. THE 510K: K151623.

Additional Manufacturer Narrative · 1

THE TUBING WAS FILLED WITH COAGULATED BLOOD. THE BLOOD INSIDE THE BLUE SUCTION CONNECTOR WAS MANUALLY EXTRACTED, AFTER WHICH THE TUBING WAS FLUSHED WITH BLEACH. THE ROTATING MALE LUER OF THE DISTAL ASPIRATION TUBING ASSEMBLY OF THE PENUMBRA INDIGO SYSTEM ASPIRATION TUBING WAS KINKED. THE COMPLAINT HAS BEEN EVALUATED. THE INITIAL COMPLAINT INDICATED THAT THE TUBING WOULD NOT ALLOW FOR PROPER SUCTION. EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE MALE LUER AT THE DISTAL END OF THE TUBING WAS KINKED. THIS DAMAGE LIKELY CAUSED DIFFICULTY IN PROPERLY ATTACHING THE LUER TO A ROTATING HEMOSTASIS VALVE (RHV), OR ANY OTHER COMPATIBLE PERIPHERAL DEVICE. IF THE TUBING IS IMPROPERLY CONNECTED, IT MAY LEAD TO LACK OF ASPIRATION. THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

Description of Event or Problem · 1

THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A LARGE VESSEL OCCLUSION USING A PENUMBRA SYSTEM MAX ASPIRATION TUBING. DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE ASPIRATION TUBING; HOWEVER,IT WOULD NOT ALLOW ASPIRATION. THE PROCEDURE CONTINUED SUCCESSFULLY USING ANOTHER ASPIRATION TUBING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
408584	PENUMBRA SYSTEM MAX ASPIRATION TUBING	NRY	NRY	PENUMBRA, INC.		F62779

Patients

Seq	Age	Sex	Outcome	Treatment
1