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

Catalog Number PMXENGN

Device Problems Suction Problem (2170); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00748.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine (engine) and a penumbra engine canister (canister).During the procedure, the physician reported that the canister would not seat properly and would not aspirate properly.As a result, the engine had become saturated with blood where it comes into contact with the canister and blood had dripped down onto the stem of the engine where the canister sits.The physician then decided to remove the engine to prevent blood from being aspirated into the pump body and found that the grey foam piece on the canister that comes into contact with the engine was missing.The engine was, therefore, no longer used in the procedure, and the procedure was completed using a penumbra system aspiration pump max (pump max).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report: 1.Lot #.2.Serial #.3.Device manufacture date.Results: no blood was present on the aspiration interface of the penumbra engine (engine).Conclusions: evaluation of the returned engine revealed a device capable of producing sufficient vacuum pressure.During functional testing, the engine was able to generate a vacuum pressure in specification with a demonstration canister.A substance resembling dried blood was present on the bottom of the canister well.The canister identified in the procedure was not returned for evaluation.Penumbra engines are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2019-00748.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8529754
• MDR Text Key: 142487675
• Report Number: 3005168196-2019-00749
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (y/n): Y
• PMA/PMN Number: K180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/20/2019

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: PMXENGN
• Device Lot Number: S10120-62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• 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: 03/20/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1