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

Catalog Number	PAPS3
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the lid to the canister was not seated properly.Conclusions: evaluation of the returned canister revealed that the lid was not seated properly.This likely occurred due to improper placement of the lid during the assembly process at the supplier.During the functional test, the canister was placed on a demonstration pump.The pump was powered on and no aspiration was observed.The lid to the canister was seated properly by the penumbra investigator and the pump was powered on the vacuum was observed.Penumbra engine canisters are 100% functionally tested during in-process inspection at 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 removed the canister multiple times from the penumbra engine (engine) and re-seated it; however, the canister failed to produce vacuum.It was reported that only two of the four indicator lights would illuminate.The procedure was completed using a new canister.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report 3005168196-2019-01801: 1.Section h.Box 6.Results code 1.2.Section h.Box 6.Conclusions code 1.3.Section h.Box 10./11.Narrative/corrected data.Results: the lid to the canister was not seated properly.Conclusions: evaluation of the returned canister revealed that the lid was not seated properly.During the functional test, the engine was producing aspiration but none was being measured at the canister.It was determined that the lid to the canister was not seated properly resulting in an open canister.The lid was re-seated by the penumbra investigator and vacuum pressure within specification was measured at the canister.The lid being misaligned likely contributed to the insufficient vacuum.The root cause of the lid being misaligned could not be determined.Penumbra engine canisters are 100% functionally tested during in-process inspection at the supplier.Section h.Box 6.Results code 1: 4247 - the lid of the canister was not seated properly and was misaligned.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the lid being misaligned.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: 9120761
• Report Number: 3005168196-2019-01801
• Device Sequence Number: 3643166
• 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,Followup
• Report Date (Section B): 08/27/2019
• 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: S10299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005