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

Catalog Number	PAPS2
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure of the acute cerebral infarction in the m1 segment of the middle cerebral artery (mca) using a pump max canister (canister).During the procedure, after placing the canister on the penumbra system aspiration pump max 110v (pump max) and connecting the aspiration tubing (tubing) to a penumbra system 4max reperfusion catheter (4maxc), the lid of the canister became dented after aspiration had started at -28 inhg.After making a successful pass with the 4maxc, the physician decided to discontinue using the canister.Therefore, the canister was removed.The procedure was completed using a new canister with the same 4maxc, a non-penumbra stent retriever, the same tubing and the same pump max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the canister was undamaged.Conclusions: evaluation of the returned canister revealed an undamaged, functional device.There was no noticeable damage observed to the canister during functional testing.The reported complaint could not be confirmed.Penumbra canisters are 100% visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PUMP MAX CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8552613
• Report Number: 3005168196-2019-00820
• Device Sequence Number: 360846
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• 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): 03/28/2019
• 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: PAPS2
• Device Lot Number: F87627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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