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

Model Number PAPS3

Device Problem Suction Problem (2170)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-02373.

Event Description

The patient was undergoing a thrombectomy procedure to treat a right carotid t occlusion using a penumbra engine (engine) and a penumbra engine canister (canister).During the procedure, the canister was placed onto the engine and then the engine was powered on.Subsequently, no vacuum was observed; therefore, the canister was removed and replaced with a new canister.Afterwards, two passes were completed using the engine and the new canister.During the third pass, it was observed that the engine did not generate any vacuum.Therefore, the engine and canister were removed.The procedure was completed using manual aspiration with a syringe.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received indicated that the device is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2020-02373 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: 11097865
• MDR Text Key: 225112859
• Report Number: 3005168196-2020-02374
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019758
• UDI-Public: 00814548019758
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/03/2020

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
• Device Catalogue Number: PAPS3
• Device Lot Number: S11751
• Was Device Available for Evaluation?: No
• 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: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR