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

Model Number	IAPS3
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-01288.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the coronary artery using a penumbra engine (engine) and penumbra engine canister (canister).During the procedure, the physician noticed none of the indicator lights on the engine would illuminate and the engine was not generating aspiration.The grommets near the canisters were removed in an attempt to troubleshoot; however, it was unsuccessful.It was also reported that the vacuum release lever was depressed.Therefore, engine was removed.The procedure was completed using a manual aspiration catheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11971312
• Report Number: 3005168196-2021-01289
• Device Sequence Number: 14510431
• Product Code: QEW
• UDI-Device Identifier: 00814548019765
• UDI-Public: 00814548019765
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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
• Report Date (Section B): 05/14/2021
• 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: IAPS3
• Device Catalogue Number: IAPS3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005