MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM MAX ASPIRATION TUBING; NRY

Model Number	PST2
Medical Device Problem Codes	Fracture (1260); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).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 penumbra system max aspiration tubing (tubing).During the procedure, the tubing did not aspirate at all and was found to be cracked.Therefore, the tubing was removed.The procedure was completed using new tubing.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned tubing confirmed, the devices inability to aspirate fluid properly, but could not confirm the reported crack.During functional testing, the tubing was connected to a demonstration pump max and canister and was able to aspirate fluid at a slow rate.While aspirating fluid, a hissing noise could be heard coming from the ¿on/off¿ switch, and fluid could be seen on the outside of the flow switch.The tubing was flushed with air, while submerged in water.And bubbles could be seen exiting the device from the ¿on/off¿ switch, when the switch was set to ¿on¿.But no leak occurred, when it was set to ¿off¿.No cracks were observed.Therefore, the cause of the leak could not be determined.Penumbra aspiration tubing are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed.And did not reveal any outstanding discrepancies, design, or quality concerns.Section h: box 6, conclusions code 1: 4316: the investigation findings do not lead to a clear conclusion about the cause of leak.H3 other text: placeholder.

• Brand Name: PENUMBRA SYSTEM MAX ASPIRATION TUBING
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12744690
• Report Number: 3005168196-2021-02485
• Device Sequence Number: 14572694
• Product Code: NRY
• UDI-Device Identifier: 00814548012025
• UDI-Public: 00814548012025
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021
• 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 Expiration Date: 06/16/2023
• Device Model Number: PST2
• Device Catalogue Number: PST2
• Device Lot Number: F98393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005