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

Catalog Number PMXENGN

Device Problems Suction Problem (2170); Failure to Shut Off (2939)

Patient Problem No Information (3190)

Event Date 02/07/2019

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 middle cerebral artery (mca) using a penumbra engine (engine).During the procedure, four lights illuminated on the engine and the physician completed one pass in the target vessel with full aspiration.However, during the subsequent three passes, only two or three lights illuminated and the engine could not sustain full aspiration.The physician then decided to stop the procedure after the fourth pass.It was also reported that the engine would not power off when the power button was pressed.On 12-feb-2019 we received additional information noting that the patient was "not doing well".No further information was provided.

Manufacturer Narrative

Results: during visual testing it was noted that the rubber foot had fallen off the pump and was returned taped to its side.Conclusion: evaluation of the returned engine revealed the device was able to power on and produce vacuum within specification.At full vacuum, all 4 led lights were illuminated.Further functional testing revealed the power button came stuck intermittently.Also, one of the rubber feet had become detached from the base of the pump and is incidental.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: 8404089
• MDR Text Key: 138256770
• Report Number: 3005168196-2019-00430
• 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: 01/01/2005,02/07/2019

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: S10120-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• 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: 02/07/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1