MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; NRY

Model Number	PAPS3-A
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01477.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the top of the basilar artery (ba-top) using a penumbra engine (engine), a penumbra engine canister (canister), a penumbra system ace 68 reperfusion catheter (ace68), and a stent retriever.During the procedure, the physician removed the stent retriever after completing one pass and subsequently initiated aspiration.However, the engine stopped aspirating and it was reported that no indicator lights were illuminated and the engine was not increasing in pressure.Troubleshooting was performed but the issue remained unresolved.Therefore, the engine and canister were no longer used in the procedure.The procedure was completed using manual aspiration and the same ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the canister.Conclusions: evaluation of the returned canister revealed a functional device.During the functional test, the canister was connected to a demonstration engine pump and achieved vacuum pressure within specification and all four vacuum indicator lights on the engine illuminated.The reported complaint could not be confirmed.The supplier performs 100% visual and functional inspection prior to shipping to penumbra.Penumbra performs packaging and label inspection upon receipt prior to shipment to customer.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10532202
• Report Number: 3005168196-2020-01476
• Device Sequence Number: 2902608
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005