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

Model Number PMXENGN-A

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

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 internal carotid artery (ica) using a penumbra engine (engine), penumbra canister, aspiration tubing (tubing) and penumbra system jet 7 reperfusion catheter (jet7).During the procedure, the physician placed the canister in the engine and connected the jet7 to the engine via the tubing.The physician then advanced the jet7 to the face of the clot and powered on the engine.The led lights on the canister were illuminated, but the engine was unable to aspirate and did not make its usual sound.Subsequently, a penumbra employee made four attempts to troubleshoot the engine by unplugging the engine, pulling out the canister, and disconnecting the tubing, but the issue with the engine was not resolved.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using manual aspiration with a syringe.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the power indicator lights, and the cooling fans were able to turn on but no vacuum pressure was observed.Therefore, the device housing was opened and the ribbon cable wires leading to the vacuum pump were damage.Conclusions: evaluation of the returned engine confirmed that the device was unable to produce vacuum.During functional testing, the power indicator lights, and cooling fans were able to be activated but no vacuum was observed.Therefore, the device housing was opened and wires leading to the vacuum pump were damaged.The damage to the wires likely contributed to the engine does not function properly during the procedure.Penumbra engines are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10040602
• MDR Text Key: 190480093
• Report Number: 3005168196-2020-00637
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• 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: 01/01/2005,04/16/2020

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: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• 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: 04/16/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR