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

Catalog Number PMXENGN

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2019

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 middle cerebral artery (mca) using a penumbra engine (engine).During the procedure, the physician advanced a penumbra system jet 7 reperfusion catheter (jet7) to nearly the m2 segment of the mca, connected it to the engine and attempted to aspirate the clot; however, the clot was not aspirated.The physician then attempted another pass using the engine with the same jet7; however, the clot was not aspirated.It was reported that not all the engine lights were illuminated despite being troubleshooted by a hospital technologist; therefore, the engine was removed.The procedure was completed using a penumbra system aspiration pump max 110 (pump max) with a non-penumbra stent retriever device and the same jet7.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the engine was powered on and able to produce a vacuum pressure of approximately -29.0 inhg.A demonstration canister was seated on the returned engine and was able to hold a vacuum pressure of approximately -28.0 inhg with all four vacuum indicator lights illuminated.Conclusions: evaluation of the returned engine revealed a functional device.The engine was able to produce a vacuum pressure within specification with all four vacuum indicator lights illuminated.The reported complaint was unable to be confirmed.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: 8955756
• MDR Text Key: 156294366
• Report Number: 3005168196-2019-01667
• 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: 01/01/2005,08/05/2019

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: PMXENGN
• Device Lot Number: S10114-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• 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: 08/05/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR