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 12/16/2019

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 in the m1 segment of the middle cerebral artery (mca) using a penumbra engine (engine).During the procedure, the hospital staff observed that only two of the four indicator lights on the engine were illuminated, and the engine was generating half aspiration; therefore, it was removed.The procedure ended at this point, and a thrombolysis in cerebral infarction (tici) grade 1 recanalization was achieved.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2019-00702.Results: the engine was powered on the was able to produce vacuum pressure within specification.A demonstration test canister was seated onto the engine.When powered on, the engine was able to produce vacuum within specification with all four vacuum indicator lights illuminated.Conclusions: evaluation of the returned engine revealed a fully functional device.With a demonstration canister seated onto the engine, the engine was able to produce vacuum within specification with all four vacuum indicator lights illuminated.The reported complaint was unable to be confirmed.No abnormalities were identified which may cause or contribute to the reported issue.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.

Manufacturer Narrative

Correction: section h10 was incorrectly reported on follow-up #01 mfr and is being corrected on this follow-up #2 mfr report:3005168196-2020-00008.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2020-00008.Results: the engine was powered on the was able to produce vacuum pressure within specification.A demonstration test canister was seated onto the engine.When powered on, the engine was able to produce vacuum within specification with all four vacuum indicator lights illuminated.Conclusions: evaluation of the returned engine revealed a fully functional device.With a demonstration canister seated onto the engine, the engine was able to produce vacuum within specification with all four vacuum indicator lights illuminated.The reported complaint was unable to be confirmed.No abnormalities were identified which may cause or contribute to the reported issue.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.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9560662
• MDR Text Key: 176997544
• Report Number: 3005168196-2020-00008
• 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: 01/01/2005,12/16/2019

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 Model Number: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10135-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• 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: 12/16/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/07/2020; 01/14/2005
• Supplement Dates FDA Received: 01/28/2020; 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR