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

Model Number	PAPS3-A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra engine canister (canister), aspiration tubing (tubing), a penumbra engine (engine), a penumbra system ace 60 reperfusion catheter (ace60), and a non-penumbra stent retriever.During the procedure, the tubing was connected to the patient and aspiration was initiated.However, none of the engine indicator lights were illuminated.The physician reset the engine but the issue was not resolved.Next, the physician decided to remove the canister and exchange it for a new one.It was also reported that the lid of the canister felt loose.The procedure was then completed using the new canister, the same engine, the same tubing, the same ace60, and the same stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the canister was undamaged.Conclusions: evaluation of the returned canister could not confirm the reported complaint.During functional testing, the canister was seated onto a demonstration engine and the engine was able to achieve vacuum pressure within specification and all four vacuum indicator lights illuminated.Penumbra pump canisters are 100% visually inspected and functionally tested during in-process inspection by the supplier.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: 10451953
• Report Number: 3005168196-2020-01283
• Device Sequence Number: 3317001
• 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): 07/28/2020
• 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: No Information
• Device Model Number: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005