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

Model Number PMXENGN-A

Device Problem Suction Failure (4039)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the right internal jugular using the lightning aspiration tubing (lightning), indigo system cat12 aspiration catheter (cat12), and penumbra engine (engine).During the procedure, the physician advanced the cat12 to the face of the clot and turned the power on the engine; however, there was no aspiration.It was reported that the lights around the power button on the engine were illuminated but the engine was unable to produce aspiration.Therefore, the engine was removed.The procedure was completed using a penumbra system aspiration pump max 110 (pump max).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2020-01685 1.Section h.Box 5.Labeled for single use? results: the engine was able to power on, but no vacuum pressure was observed.Only the power indicator lights, and the cooling fans were turned on.Therefore, the device housing was opened and observed that the ribbon cable wires leading to the vacuum pump were damaged.Conclusions: evaluation of the returned engine confirmed that the device was unable to produce aspiration.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 it was observed that the wires leading to the vacuum pump were damaged.The damage to the wires likely contributed to the engine unable to produce aspiration 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: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10657166
• MDR Text Key: 210707385
• Report Number: 3005168196-2020-01685
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (y/n): Y
• PMA/PMN Number: K180105
• 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: 01/01/2005,09/16/2020

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: 09/24/2020
• 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: 09/16/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR