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

Catalog Number	3MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
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.This report is associated with mfr report number: 3005168196-2023-00020.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system 3max reperfusion catheter (3maxc), benchmark bmx96 access system (bmx96), penumbra system red72 reperfusion catheter (red72), a penumbra engine canister (canister), and guidewire.During the procedure, the physician advanced the red72 through the bmx96 and made the first pass in the target vessel using the red72.Next, the physician advanced the red72 over the 3maxc and then removed the 3maxc to make the second pass using the red72.Subsequently, upon inspecting the canister for clot, the physician noticed the distal end of the 3maxc had broken off and was aspirated with the red72 and into the canister.Therefore, the 3maxc was not used for the remainder of the procedure.It was also reported that the clot migrated from the ica to the m2 segment of the mca, and the physician decided to remove the red72 and switch to a penumbra system red 62 reperfusion catheter (red62).The procedure was completed using a velocity delivery microcatheter (velocity) and red62.
Additional Manufacturer Narrative
Emboli is included as a possible complication in the instructions for use (ifu) for the penumbra system reperfusion catheter evaluation of the returned 3maxc confirmed a fracture on the distal shaft.Evaluation revealed that the device was stretched proximal to the fractured location.If the 3maxc is retracted against resistance, it may become stretched and may subsequently fracture.The distal fractured segment was not returned for evaluation.Further evaluation revealed kinks and ovalization within the stretched location on the catheter shaft.This type of damage may occur if the device is manipulated against resistance.Based on the reported event, the root cause of the resistance could not be determined.Penumbra catheters 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.This report is associated with mfr report number: 1.3005168196-2023-00020.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• 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: 16141857
• Report Number: 3005168196-2023-00019
• Device Sequence Number: 12394438
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2025
• Device Catalogue Number: 3MAXC
• Device Lot Number: F00003036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005