MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Model Number	PNML6F088904M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a neuron max 6f 088 long sheath (neuron max) and a penumbra system ace 60 reperfusion catheter (ace60).During the procedure, the physician noticed that a neuron max was ovalized upon removal from the packaging.Subsequently, the physician attempted to advance an ace60 through the neuron max but was unsuccessful.Therefore, the neuron max was removed.The procedure was completed using a new neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max revealed, multiple ovalizations throughout the length of the catheter.If the device is retracted from its packaging at an extreme angle or is otherwise mishandled, during preparation for use, damage such as ovalizations may occur.During functional testing, resistance was experienced, while attempting to advance a demonstration ace 60 through the neuron max, due to the ovalization, and the ace 60 could not be advanced through.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 is being updated based on additional information provided by a penumbra distributor on 05-sept-2022: 1.Section b.Box 5.Describe event or problem it was previously reported that the ovalization occurred while in use in the patient.However, based on the updated information, the ovalization occurred upon removal from the packaging prior to use in the patient.Note: although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.Therefore, this is not considered a reportable event.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a neuron max 6f 088 long sheath (neuron max) and a penumbra system ace 60 reperfusion catheter (ace60).During the procedure, the physician noticed that a neuron max was ovalized upon removal from the packaging.The damage to the neuron max was found prior to use and, therefore, the neuron max was not used in the procedure.The procedure was completed using a new neuron max and the same ace60.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• 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: 12583511
• Report Number: 3005168196-2021-02204
• Device Sequence Number: 19655590
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K111380
• 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): 10/21/2022
• 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: 01/14/2023
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H10262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• 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: 09/08/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 09/05/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/22/2021; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2020
• 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: 89 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005