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

Model Number	IAPS3-A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
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 in the pulmonary artery using a penumbra engine canister (canister) and a penumbra engine (engine).During the procedure, the canister was placed in the engine, and none of the four indicator lights on the engine illuminated.Then, the penumbra staff attempted to troubleshoot by resecuring the canister and restarting the engine.However, the issue was not resolved; therefore, the canister was removed.The procedure was completed using a new canister and the same engine.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: no damage was observed on the canister.Conclusions: evaluation of the returned canister revealed an undamaged and functional device.During functional testing, the canister was seated onto a demonstration engine and was able to produce a vacuum pressure within specification.All four vacuum indicator lights on the engine illuminated.The reported complaint could not be confirmed.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10124536
• Report Number: 3005168196-2020-00732
• Device Sequence Number: 16739034
• Product Code: DXE
• UDI-Device Identifier: 00814548019703
• UDI-Public: 00814548019703
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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): 05/13/2020
• 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-A
• Device Catalogue Number: IAPS3
• Device Lot Number: S11547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 93
• Date Report Sent to FDA: 01/01/2005