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

Catalog Number	PAPS3
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra engine canister (canister) lid was not completely secure on the canister body.Conclusions: evaluation of the returned canister revealed the lid was not properly secure on the canister body.If this occurs, the canister may not produce sufficient vacuum.During functional testing, the lid was properly tightened onto the canister body and was seated onto a demonstration engine and was able to produce vacuum within specification and all four vacuum indicator lights were illuminated.The root cause of this issue could not be determined.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra engine canister (canister).During the procedure, the hospital staff noticed that the canister was not holding pressure; therefore, the canister removed.A second canister and the penumbra engine (engine) were not used to continue the procedure; it was reported that by the time the second canister was brought in to the room, the physician had already used a 60cc syringe.The procedure was completed using an aspiration method with the 60cc syringe.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9336802
• Report Number: 3005168196-2019-02129
• Device Sequence Number: 2244118
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2019
• 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 Catalogue Number: PAPS3
• Device Lot Number: S11513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/18/2019
• 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