MAUDE Adverse Event Report: PENUMBRA INC. PNEUMBRA ENGINE CANISTER; CATHETER, THROMBUS RETRIEVER

Model Number PAPS3

Device Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

Event Type  malfunction  

Event Description

During stroke case, suction canister for stroke was correctly installed in the suction device and would not provide the proper suction.Physician attempted to clear the line and though the line was cleared, the canister would still not provide proper suction.The canister was replaced mid-case adding unnecessary time to the procedure.Once the canister was replaced, proper suction as attained and the procedure continued.

• Brand Name: PNEUMBRA ENGINE CANISTER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA INC.
• MDR Report Key: 11946719
• MDR Text Key: 254916059
• Report Number: MW5101741
• Device Sequence Number: 1
• Product Code: NRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PAPS3
• Device Lot Number: S11806
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR