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

Catalog Number	3MAXCKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2022
Type of Reportable Event	Malfunction
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), a penumbra system ace 68 reperfusion catheter (ace68), and a guidewire.During the procedure, the 3maxc was advanced to the target location and used to perform aspiration.While withdrawing the 3maxc from the ace68, resistance was encountered and the 3maxc became stuck when the distal end of the 3maxc was approximately one millimeter outside of the ace68.The physician continued to retract the 3maxc over the guidewire and subsequently, the 3maxc broke in two pieces at the proximal end.Therefore, the ace68 containing the broken 3maxc was removed from the patient.It was also reported that the 3maxc was crushed and kinked near the location of the break at the proximal end.At this point, the procedure was successfully completed and no additional passes were required.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 3maxc confirmed a fracture.Further evaluation revealed that the device was ovalized and stretched on both sides of the fracture.This type of damage may occur if the 3maxc is manipulated against resistance.The ovalization on the returned ace68 likely contributed to the resistance and the 3maxc becoming stuck during the procedure.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.

• 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: 16188067
• Report Number: 3005168196-2023-00030
• Device Sequence Number: 6131973
• Product Code: NRY
• UDI-Device Identifier: 00814548016757
• UDI-Public: 814548016757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2024
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F109407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2022
• 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: 12/21/2022
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005