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

Catalog Number PAPS2

Device Problems Suction Problem (2170); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2019

Event Type  malfunction  

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 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.

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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8898474
• MDR Text Key: 154464153
• Report Number: 3005168196-2019-01585
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/17/2019

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
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR