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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 reperfusion catheter (ace60) and a stent retriever.During the procedure, when the physician removed the ace60 and the stent retriever together from the patient, it was found that the distal length of the ace60 was fractured.No additional information was provided regarding the completion of the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), a neuron max 6f 088 long sheath (neuron max), and a stent retriever.It should be noted that the patient''s anatomy was tortuous.During the procedure, after making many passes using the ace60 and the stent retriever, the physician experienced resistance while retracting the stent retriever out of the ace60.It was also reported that the physician experienced resistance while removing the ace60 and the stent retriever together from the patient.After removing the devices, the physician found that the distal length of the ace60 was fractured.The procedure was completed using the same neuron max, a non-penumbra catheter, and the same stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the distributor on 05/23/2024: 1.Section b.Box 5.Describe event or problem.1.Section h.Box 6.Evaluation codes: device code 2.Evaluation of the returned ace60 confirmed that the catheter was fractured.The complaint stated that resistance was experienced while retracting the ace60 and non-penumbra stent retriever together.If the ace60 is retracted against resistance, damage such as a fracture may occur.Further evaluation revealed a kink on the catheter shaft, and discoloration on the distal tip of the ace60.This damage was incidental to the reported complaint.The discoloration on the distal tip may have occurred due to tip shaping the catheter prior to the procedure.The kink likely occurred during packaging of the device for return to penumbra.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 and is being included on this follow-up #02 mfr report:3005168196-2024-00156.1.Section g.Box 4.Date received by manufacturer.

• 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: 19152819
• Report Number: 3005168196-2024-00156
• Device Sequence Number: 15578695
• 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,Followup
• Report Date (Section B): 06/24/2024
• 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: 12/27/2025
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F00004789
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 01/14/2005; 06/07/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/13/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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: 60 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005