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

Model Number	PNML6F088904-R
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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 m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system red 72 reperfusion catheter (red72), a neuron select catheter 6f (6f select), and a guidewire.During the procedure, the physician used the neuron max and 6f select to gain access to the target vessel.Upon removal of the 6f select, the physician kinked the neuron max near the hub.Then the physician attempted to advance the red72 through the neuron max; however, the red72 would not advance.Therefore, the neuron max was removed.The procedure was completed with one pass using the same red72, a penumbra system 3max reperfusion catheter (3maxc), and a bmx96 access system (benchmark max).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max confirmed a kink near the hub.This damage was reported to have occurred during removal of the 6f select from the neuron max during the procedure.If the neuron max is forcefully mishandled at extreme angles during use, damage such as a kink may occur.During functional testing, a demonstration 6fselect was unable to advance through the neuron max due to the kink near the hub.Further evaluation revealed ovalizations throughout the length of the neuron max.This damage was likely incidental to the reported complaint and may have occurred during packaging 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.

• 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: 12651681
• Report Number: 3005168196-2021-02287
• Device Sequence Number: 18219391
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021
• 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: 01/14/2024
• Device Model Number: PNML6F088904-R
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H11094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• 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: 09/24/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005