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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned 3maxc confirmed an ovalized region and leak on the distal end.Based on the ability to advance halfway through the guide catheter, this damage likely occurred during retraction of the 3max or outside of the patient.If the distal end was inadvertently retracted at a sharp angle from the guide catheter it may have become ovalized on the distal region.This ovalization would prevent fluid from being pushed through the device.If fluid was forcefully pushed through the flattened region of the device, it may have caused the damage portion of the catheter to leak.The root cause of the difficulty advancing could not be determined.The returned device was not able to be advanced into the hub of a demonstration guide catheter due to the distal tip damage.Penumbra catheters are visually 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the posterior cerebral artery using a penumbra system 3max reperfusion catheter (3maxc), non-penumbra guide catheter, guide, and guidewire.It was reported that the 3maxc and guide catheter were flushed with saline prior to use.During the procedure, the physician experienced resistance when advancing the 3maxc through the middle of the guide catheter.The 3maxc was removed and upon flushing on the back table using a syringe, the distal tip of the 3maxc was ovalized.Therefore, the 3maxc was not used for the remainder of the procedure.The procedure was completed using a new 3maxc and the same guide catheter.There was no report of an adverse effect to the patient.

• 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: 11704127
• Report Number: 3005168196-2021-00814
• Device Sequence Number: 3499509
• 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
• Report Date (Section B): 03/23/2021
• 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: 02/18/2022
• Device Model Number: 3MAXCKIT
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F88593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• 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: 03/23/2021
• Initial Report FDA Received Date: 04/21/2021
• 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