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

Model Number PAPS3-A

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

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 internal carotid artery (ica) using a penumbra engine canister (canister), a penumbra engine (engine), a penumbra system jet 7 reperfusion catheter (jet7), and a non-penumbra guide catheter.During the procedure, the physician advanced the jet7 towards the target vessel and simultaneously powered on the engine.It was reported that none of the indicator lights illuminated.The physician checked the seal of the canister lid as well as the connection to the aspiration tubing (tubing), then turned the engine on and off; however, the problem persisted.Therefore, the canister was removed.The procedure was completed using a new canister, the same engine, the same jet7, and the same guide catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: there was no damage 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 vacuum within specification.All four vacuum indicator lights on the engine illuminated.The root cause of 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.H3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9988781
• MDR Text Key: 188644723
• Report Number: 3005168196-2020-00587
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (y/n): Y
• PMA/PMN Number: K180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/29/2020

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 Model Number: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• 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: 03/29/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1