MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Model Number	5MAXACE132-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ace60 revealed that the proximal shaft was kinked.This damage is likely the reported mid-shaft kink.If the device is forcefully advanced against resistance during the procedure, damage such as this may occur.This damage likely contributed to the reported aspiration issue during the procedure.Further evaluation of the device revealed that the proximal shaft was ovalized at the kinked location.If the device is forcefully mishandled during use, damage such as an ovalization may occur.This ovalization likely contributed to the resistance during advancement and forceful advancement against this resistance likely contributed to the observed kinks in the proximal shaft.During functional testing, resistance was encountered due to the ovalization while advancing the ace60 through a demonstration neuron max and the ace60 could not be advanced any further.Evaluation revealed ovalization at the distal tip.This damage was likely incidental to the complaint.During functional testing, the ace60 was able to aspirate water without issue.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) and the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician advanced the ace60 through the neuron max into the target location.The physician then initiated aspiration; however, it was noticed that no thrombus could be aspirated out.Subsequently, it was noticed that the ace60 was kinked at the mid-shaft.Therefore, the ace60 was removed.The procedure was completed using a non-penumbra stent and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 60 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: 12824441
• Report Number: 3005168196-2021-02591
• Device Sequence Number: 11123069
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• 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
• Report Date (Section B): 11/16/2021
• 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: 08/13/2022
• Device Model Number: 5MAXACE132-A
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F92469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• 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: 10/20/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• 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: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005