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

Catalog Number	PAPS3
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra engine canister (canister) and a penumbra engine (engine).During the procedure, it was reported that the engine did not aspirate properly and only one indicator light was illuminating.The canister was re-installed; however, no improvement was noted.Therefore, the canister was removed.The procedure was completed using a new canister and the same engine.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the canister lid was not properly sealed on the canister body.Conclusions: evaluation of the returned canister revealed that the canister lid was not properly sealed on its body.This damage likely contributed to the inability to aspirate properly during the procedure.The returned canister was covered with blood; therefore, functional testing could not be performed.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.H3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10834812
• Report Number: 3005168196-2020-01982
• Device Sequence Number: 3274771
• Product Code: NRY
• UDI-Device Identifier: 00814548019758
• UDI-Public: 00814548019758
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020
• 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 Catalogue Number: PAPS3
• Device Lot Number: S11654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005