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

Model Number	PNML6F088804M
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	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 medical procedure in the cavernous segment of the internal carotid artery using a neuron max 6f 088 long sheath (neuron max) and a non-penumbra guiding catheter.During the procedure, the physician experienced resistance while attempting to advance the neuron max in the common carotid artery.Therefore, the physician placed a guiding sheath inside the neuron max for support.The physician then advanced the guiding sheath and neuron max in the common carotid artery and down the aorta.While advancing the guiding sheath and neuron max to the brachiocephalic artery, the physician experienced resistance and subsequently, the physician could not navigate the guiding catheter.Therefore, the neuron max and guiding catheter were removed together.After the removal of the neuron max and guiding catheter, the physician noticed that the distal end of the neuron max was kinked, and the outer layer was peeled off.The procedure was completed using a new neuron max and the same guiding catheter.There was no report of an adverse effect to the patient.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12566300
• Report Number: 3005168196-2021-02183
• Device Sequence Number: 16497757
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2021
• 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: 03/20/2022
• Device Model Number: PNML6F088804M
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F90238
• Was Device Available for Evaluation?: No
• 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: 09/05/2021
• Initial Report FDA Received Date: 10/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005