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

Catalog Number	IAPS3
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system engine canister (canister).During the procedure, it was reported that only two lights were illuminating on the penumbra system engine (engine).The technician then applied pressure to the canister and all four lights illuminated.The procedure was then continued in this manner.When the physician was making the third pass, it was reported that only three lights were illuminating on the engine; however, the procedure was completed successfully.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned canister was undamaged.The returned canister was seated onto a demonstration engine and was able to hold a vacuum pressure of approximately -27.0 inhg with all four vacuum indicator lights illuminated.Conclusions: evaluation of the returned canister revealed the device was capable of holding vacuum pressure within specification.The reported inconsistent canister pressurization was unable to be confirmed.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8689139
• Report Number: 3005168196-2019-01132
• Device Sequence Number: 14208290
• Product Code: NRY
• UDI-Device Identifier: 00814548019703
• UDI-Public: 00814548019703
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019
• 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 Catalogue Number: IAPS3
• Device Lot Number: S10258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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