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

Catalog Number PAPS3

Device Problems Positioning Failure (1158); Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2019

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

During preparation for a thrombectomy procedure, a penumbra engine canister (canister) would not seat properly on the penumbra engine.The physician then tightened the canister and tried to seat it properly, but noted that the issue would not resolve.It was also reported that only three of the four indicator lights would illuminate.Therefore, the canister was replaced and the procedure was successfully completed.

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 was disposed of and 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.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8692622
• MDR Text Key: 147782264
• Report Number: 3005168196-2019-01149
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/14/2019

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
• Device Lot Number: S10255
• 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: 05/14/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1