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

Model Number	PAPS3-A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00851.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra engine canister (canister), penumbra engine (engine), aspiration tubing (tubing), penumbra system jet 7 reperfusion catheter (jet7), and non-penumbra microcatheter.During the procedure, the physician placed a canister in the engine, and after it was powered on, the four indicator lights on the engine were not illuminated.The physician was concerned that there was a bad connection with the engine and jet7, which were connected by the tubing; subsequently, the physician held the tubing with forceps but was not able to resolve the issue.The physician then removed the tubing from the engine, placed their finger onto the suction port of the engine, and noted that they did not feel the vacuum pressure; therefore, the canister was removed.Next, the physician placed another canister in the engine.The four indicator lights on the engine were initially illuminated but later decreased to two indicator lights.The procedure was completed using the second canister and same engine.It was reported that while the vacuum pressure was not stable, a thrombolysis in cerebral infarction (tici) 3 was achieved with one pass.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the canister.Conclusions: evaluation of the returned canister revealed no visible damage and a functional device.During the functional test, the returned canister was placed on a demonstration engine pump and all four vacuum lights illuminated without an issue.The root cause of the reported complaint could not be determined.The supplier performs 100% visual and functional inspection prior to shipping to penumbra.Penumbra performs packaging and label inspection upon receipt prior to shipment to customer.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2020-00851.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10215803
• Report Number: 3005168196-2020-00850
• Device Sequence Number: 2565217
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Model Number: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005