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

Model Number	PMXENGN-A
Medical Device Problem Codes	Break (1069); Vibration (1674); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra engine (engine).During the procedure, the engine fell off the table due to vibrations thereby causing the vacuum release lever to break.The pump fell prior to the catheter being advanced into the patient.The four led lights were on and the physician found the engine to be functional.The procedure was completed using the same engine.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine revealed a functional device.During functional testing, the engine was tested with a demonstration canister and was able to achieve vacuum pressure within specification and all four vacuum indicator lights illuminated.There was no observation of the engine vibrating along the table and the reported broken vacuum release lever was unable to be confirmed.Further evaluation revealed one of the five rubber feet on the bottom of the engine was missing.This damage may be incidental to the reported complaint.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
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11939356
• Report Number: 3005168196-2021-01251
• Device Sequence Number: 11806163
• Product Code: QEW
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Model Number: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005