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

Model Number	PAPS3
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2019
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 m1 segment of the middle cerebral artery (mca) using a penumbra engine, a penumbra canister (canister) and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, the canister was placed onto the engine and then the ace68 was connected to the engine.Afterwards, aspiration was initiated; however, not enough vacuum was observed coming from the distal tip of the ace68.Therefore, the canister was removed.The procedure was completed using a new canister, the same engine, and the same ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned canister revealed blood inside and outside of the canister housing.Due to the returned condition, the canister was unable to be functionally tested; therefore, the root cause of the reported complaint 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11874893
• Report Number: 3005168196-2021-01152
• Device Sequence Number: 3402111
• 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): 07/14/2021
• 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
• Device Catalogue Number: PAPS3
• Device Lot Number: S11751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005