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

Model Number PMXENGN-A

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

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 bilateral pulmonary artery using a penumbra engine (engine) and penumbra engine canisters (canister).During the procedure, it was reported that multiple canisters would not seat properly on the engine.Therefore, the engine was removed.The procedure was completed using a new engine and the same canisters.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the engine pumps housing was not seated properly onto the base.Conclusions: evaluation of the returned engine confirmed that a demonstration canister was unable to seat properly on the engine.Further evaluation revealed that the engines housing was not seated properly onto its base.The engines housing was opened, and a screw port was found to be damaged.The root cause of these damages could not be determined; however, these damages likely contributed to the reported complaint.The engines housing was seated properly onto its base, and a demonstration canister was then able to be seated onto the engine.The engine was able to produce vacuum pressure within specification and all four vacuum 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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the damaged housing that likely contributed to the reported complaint.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10312029
• MDR Text Key: 199984584
• Report Number: 3005168196-2020-00990
• 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: 01/01/2005,06/28/2020

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 Model Number: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10128-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• 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: 06/28/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR