MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.Placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter and a guidewire.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician successfully completed one pass in the target vessel and subsequently retracted the thrombus and the ace60 together.Upon removal from the patient, the physician found that the ace60 was fractured at the proximal end and remained connected by an inner wire.Therefore, the ace60 was no longer used in the procedure.The procedure was completed using a new ace60, the same neuron max, and the same microcatheter.There was no report of an adverse event to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace60 confirmed a fracture underneath the strain relief and revealed a kink distal to the fracture.If the proximal end of the ace60 is retracted against resistance during use, damage such as a kink and fracture may occur.The reported tortuous patient anatomy likely contributed to the resistance during the retraction of the device.Further evaluation of the device revealed an additional kink on the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return.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 5MAX ACE 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: 16665934
• Report Number: 3005168196-2023-00151
• Device Sequence Number: 15083331
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 814548017426
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/09/2023
• 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: 07/11/2025
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F00002030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005