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

Catalog Number PMXENGN

Device Problems Suction Problem (2170); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

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 carotid artery using a penumbra engine (engine).During the procedure, the physician noted that the engine was aspirating inconsistently.Additionally, it was reported that the led lights surrounding the penumbra engine canister (canister) were flickering on and off and the engine was making various noises "as if it were revving".The engine was therefore removed and was no longer used in the procedure.The procedure was completed using another engine.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 #3005168196-2019-01215 mfr report: 1.Section h.Box 5.Labeled for single use? 2.Section h.Box 8.Usage of device results: the returned engine was powered on and able to produce a vacuum pressure of approximately -29.5 inhg.A demonstration canister was seated onto the engine and was able to hold a vacuum pressure of approximately -28.0 inhg.During functional testing, the lights were observed flickering, but no unusual noises were observed.Conclusions: evaluation of the returned engine confirmed the canister lights would intermittently flicker but was able to produce vacuum within specification.During the functional testing no unusual noises were observed, but the lights were confirmed to flicker intermittently.The root cause of the flickering lights was unable to be determined.The inconsistent vacuum pressure and unusual noises were 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the flickering lights.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: 8724510
• MDR Text Key: 148922819
• Report Number: 3005168196-2019-01215
• 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: 01/01/2005,05/23/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• 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: 05/23/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1