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

Model Number	3MAXCKIT
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
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 middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra guide catheter, and a guidewire.During the procedure, the physician injected tissue plasminogen activator (tpa) and subsequently placed the guide catheter in the internal carotid artery (ica) and the ace68 was advanced into the carotid siphon.Next, the 3maxc was passed through the clot towards the target location.The physician removed the 3maxc and guidewire from the ace68 in order to begin aspiration and noticed that the 3maxc was stretched.Therefore, the 3maxc was no longer used in the procedure.The procedure was completed using two other stent retrievers, the same guide catheter, and the same ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 3maxc confirmed stretching on the distal shaft.If the device is forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed that a non-penumbra guidewire was returned protruding through the stretched region of 3maxc.The root cause of this damage could not be determined; however, this damage may cause resistance during manipulation of the 3maxc and guidewire within the ace68.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
• MDR Report Key: 11441264
• Report Number: 3005168196-2021-00457
• Device Sequence Number: 3497151
• 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): 02/09/2021
• 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: 02/19/2023
• Device Model Number: 3MAXCKIT
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F96376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005