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

Catalog Number	PAPS2
Medical Device Problem Codes	Suction Problem (2170); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
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 using a pump max canister (canister).During the procedure, the physician noticed the aspiration pressure would only reach -10 inhg and the canister made sound of leaking air.Therefore, the physician removed the canister and the procedure was completed using a new canister.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned canister was undamaged.Conclusions: evaluation of the returned pump max canister (canister) revealed a functional device.During the functional testing, the canister was tested with a demonstration pump max and able to produce a vacuum pressure within specification.The reported air leaking sound from the canister could not be confirmed.Penumbra canisters are 100% 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: 8898474
• Report Number: 3005168196-2019-01585
• Device Sequence Number: 16558744
• 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): 07/17/2019
• 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: F87139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Date Report Sent to FDA: 01/01/2005