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

Model Number	PAPS3-A
Medical Device Problem Codes	Connection Problem (2900); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
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 m1 and m2 segment of the middle cerebral artery (mca) using a penumbra engine canister (canister), penumbra engine (engine), and penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician advanced the jetd into the m1 and turned on the engine.It was observed that the canister was not set properly in the engine, and multiple attempts were made to resolve the issue.After the canister was set properly in the engine, the four indicator lights on the engine were not illuminated as there was not enough vacuum pressure.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
Please note that the device associated with this complaint was expected to be returned.However, additional information received from the penumbra distributor indicated that the device is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Please note that the following sections are being updated based on additional information provided by the sales representative on (b)(6) 2020: 1.Section d.Box 10.Device available for evaluation? 2.Section h.Box 3.Device returned to manufacturer? 3.Section h.Box 3.Reason for non-evaluation.4.Section h.Box 6.Reason for method codes.5.Section h.Box 6.Reason for results codes.5.Section h.Box 6.Reason for conclusions codes 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: 10838708
• Report Number: 3005168196-2020-01988
• Device Sequence Number: 3274774
• 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): 10/22/2020
• 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 Model Number: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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