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

Catalog Number PMXENGN

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

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.This report is associated with mfr report number: 3005168196-2019-01473.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra engine pump (engine) and a penumbra engine canister (canister).During the procedure, the physician reported that all lights of the engine would not illuminate and full aspiration was unable to be achieved.The physician also reported that the canister had too much foam.Therefore, the engine and the canister were removed.The procedure was completed using non-penumbra devices.No additional information is available.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up mfr report: section h.Box 5.Labeled for single use? section h.Box 8.Usage of device.Conclusion: evaluation of the returned engine revealed a functional device.During functional testing the engine was able to produce a vacuum pressure within specification with all four vacuum indicator lights illuminated.The canister associated with the complaint was not returned for evaluation.The reported complaint was unable to be confirmed.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: 3005168196-2019-01473.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow-up #01 report and is being corrected on this follow-up #02 mfr report:3005168196-2019-01472.1.Section g.Box 4.Date received by manufacturer h3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8846010
• MDR Text Key: 152790589
• Report Number: 3005168196-2019-01472
• 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,Followup
• Report Date: 01/01/2005,07/01/2019

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: S10119-61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• 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: 07/01/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/03/2019; 09/03/2019
• Supplement Dates FDA Received: 09/19/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1