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

Model Number	PAPS2
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
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 femoral and iliac veins using a pump max canister (canister).During the procedure, the physician seated the canister onto the penumbra system aspiration pump max 110 (pump max) and was able to aspirate approximately 300 cm of blood/ flush.The pump max then stopped producing vacuum; therefore, the canister was removed.The procedure was completed using another canister and the same pump max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2019-02195 1.Section e.Initial reporter name and address results: blood was observed within the lid¿s inlet.Conclusions: evaluation of the returned canister revealed that the lid¿s inlet was occluded with blood.If the inlet is occluded, a decrease in vacuum pressure may occur.The device was unable to be functionally tested; therefore, the reported complaint could not be confirmed.Penumbra pump canisters are 100% visually inspected and functionally tested during in-process inspection 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.Results code 1: 4247 - investigation results not adequately described by any other team.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of vacuum issue.

• Brand Name: PUMP MAX CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9372544
• Report Number: 3005168196-2019-02195
• Device Sequence Number: 2866853
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K180105
• 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): 10/30/2019
• 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 Model Number: PAPS2
• Device Catalogue Number: PAPS2
• Device Lot Number: S10503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Date Report Sent to FDA: 01/01/2005