MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Model Number	3MAXCKIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2020
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 in the m2 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, while flushing the 3maxc on the back table, the 3maxc was observed to be damaged.The procedure was completed using a penumbra system 4max reperfusion catheter (4maxc) and non-penumbra stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 07/28/2020: section b.Box 5.Describe event or problem.It was previously understood that the issue occurred while in use in the patient.However, based on the updated information, the issue occurred during preparation.Although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.Therefore, this is not considered a reportable event.
Event or Problem Description
During preparation for a thrombectomy procedure, a penumbra system 3max reperfusion catheter (3maxc) was flushed on the back table upon removal from the packaging and it was observed that the 3maxc was broken 930mm from the distal tip.The damage to the 3maxc was found prior to use, and therefore, the 3maxc was not used in the procedure.The procedure was completed using a penumbra system 4max reperfusion catheter (4maxc) and non-penumbra stent retriever.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10323836
• Report Number: 3005168196-2020-01024
• Device Sequence Number: 11558053
• Product Code: NRY
• UDI-Device Identifier: 00814548016757
• UDI-Public: 00814548016757
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• 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): 06/30/2020
• 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 Expiration Date: 01/23/2023
• Device Model Number: 3MAXCKIT
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F95730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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