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

Catalog Number IAPS3

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2019

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 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.

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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8689139
• MDR Text Key: 147723286
• Report Number: 3005168196-2019-01132
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019703
• UDI-Public: 00814548019703
• 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: 01/01/2005,05/13/2019

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: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1