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 07/27/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01624.

Event Description

The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) using a penumbra engine (engine) and a penumbra engine canister (canister).Upon completion of the first pass, the technician reported that the engine was not reaching full vacuum and that only three indicator lights were illuminating.The devices were then removed from the patient.Subsequently, the technician performed an angiogram and found that the thrombus had been successfully aspirated.Therefore, the procedure was successfully completed.After the patient left, the penumbra sales representative tested the engine several times using a new canister and reported that the four indicator lights illuminated after 39 seconds, 28 seconds, 31 seconds, and 30 seconds, respectively.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is longer available for return as the device was working and retained by the hospital.Therefore, without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2019-01624.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8926169
• MDR Text Key: 155405960
• Report Number: 3005168196-2019-01623
• 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: 01/01/2005,07/27/2019

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: S10115-62
• Was Device Available for Evaluation?: No
• 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: 07/27/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR