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

Catalog 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 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine (engine) and penumbra engine canister (canister).During the procedure, while attempting to start aspiration, the physician noticed that the canister would not provide adequate aspiration.It was noted that the engine sounded different and nothing went into the canister; 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.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative 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.Based on this information, corrections were made to: section d.Box 10.Device available for evaluation? (do not send to fda).Section h.Box 3.Reason for non-evaluation.Section h.Box 3.''other'' reason for non-evaluation.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10554532
• MDR Text Key: 207566680
• Report Number: 3005168196-2020-01516
• Device Sequence Number: 1
• Product Code: NRY
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/27/2020

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 Catalogue Number: PAPS3
• 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: 08/27/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR