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

Catalog Number PMXENGN

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2019

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

During preparation for a thrombectomy procedure using a penumbra engine (engine), the physician was testing the engine and reported that it would not pressurize.It was also reported that the light bars indicating vacuum pressure would not light up.The physician then removed the canister and used several other canisters in an attempt to get the engine to pressurize properly; however, the engine still did not pressurize.The issue with the engine was found prior to use and therefore, the engine was not used in the procedure.The procedure was completed using a penumbra system aspiration pump max 110 (pump max).

Manufacturer Narrative

Please note that the following section is being updated since the penumbra engine canister (canister) was also returned with the penumbra engine (engine).Describe event or problem.Results: the device housing was removed and the vacuum tubing was found to be disconnected from the vacuum sensor due to a broken sensor hub.During functional testing, the returned engine was plugged in and powered on.A calibrated gauge was seated on the engine vacuum inlet and the engine was able to generate a vacuum pressure of approximately -29.0 inhg.The returned canister was seated on the returned engine and was able to hold a vacuum pressure of approximately -26.5 inhg and no lights were illuminated.Conclusions: evaluation of the returned engine confirmed that no vacuum indicator lights were illuminating although the pump was able to power on.Upon opening the pump housing, the vacuum sensor tubing was broken from the vacuum sensor.The tubing being disconnected from the vacuum sensor prevented the led vacuum indicator lights from measuring vacuum pressure while in use and may have contributed to lower vacuum pressure.The root cause of the vacuum sensor hub breaking could not be determined.Evaluation of the returned canister revealed it was able to hold vacuum pressure within specification.During functional testing, the canister was seated on a demonstration pump and was able to hold a vacuum pressure within specification with all four indicator lights illuminated.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.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Results code 2: 4247 - the vacuum tubing was found to be disconnected from the vacuum sensor due to a broken sensor hub.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the broken sensor hub.

Event Description

During preparation for a thrombectomy procedure using a penumbra engine (engine), the physician was testing the engine and reported that it would not pressurize.It was also reported that the light bars indicating vacuum pressure would not illuminate.The physician then removed the penumbra engine canister (canister) and used several other canisters in an attempt to get the engine to pressurize properly; however, the engine still did not pressurize.The issue with the engine was found prior to use and therefore, the engine was not used in the procedure.The procedure was completed using a penumbra system aspiration pump max 110 (pump max).

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8453309
• MDR Text Key: 139897248
• Report Number: 3005168196-2019-00568
• 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: 01/01/2005,02/27/2019

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: S10127-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• 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: 02/27/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1