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

Catalog Number PMXENGN

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

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: 3005168196-2019-01631.

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 engine was not reaching full suction and that only three indicator lights were illuminating.The physician attempted to remove the canister to get it to seat better but reported that the same issue persisted.The canister was therefore removed and was no longer used in the procedure.The procedure was completed using another canister and the same engine; however, it was reported that the engine's suction was still inconsistent.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the engine was able to be powered on and produce a vacuum pressure of approximately -29.0 inhg.A demonstration canister was seated on the returned engine and was able to hold a vacuum pressure of approximately -27.5 inhg, with all four vacuum indicator lights illuminated.Conclusions: evaluation of the returned engine revealed a fully functional device.The engine was able to be powered on and produce a vacuum pressure within specification with all four indicator lights illuminated.The reported complaint was not able 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.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8940151
• MDR Text Key: 155878091
• Report Number: 3005168196-2019-01630
• 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: 01/01/2005,07/29/2019

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: S10131-32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• 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: 07/29/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR