MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX; DQY

Model Number PNML6F0881004M

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max) and a non-penumbra intermediate catheter.It was noted that the patient's anatomy was tortuous.During the procedure, the physician experienced resistance while successfully placing the neuron max into the patient.Subsequently, the physician was unable to advance the intermediate catheter through the neuron max.Therefore, the neuron max was removed.The procedure was completed using a new neuron max and the same intermediate catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned neuron max could not confirm, the reported complaint.Evaluation revealed, that the neuron max was undamaged and functional.During functional testing, a demonstration ace60 was able to advance through the neuron max without an 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.H3 other text: placeholder.

• Brand Name: NEURON MAX
• Type of Device: 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: 12619404
• MDR Text Key: 276421536
• Report Number: 3005168196-2021-02260
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012285
• UDI-Public: 00814548012285
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PNML6F0881004M
• Device Catalogue Number: PNML6F0881004M
• Device Lot Number: H10462
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male