MAUDE Adverse Event Report: PENUMBRA INC PENUMBRA NEURON MAX; CATHETER, PERCUTANEOUS

Model Number	PNML6F088904
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Penumbra neuron sheath was bent and unable to use.Fda safety report id # (b)(4).

• Brand Name: PENUMBRA NEURON MAX
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA INC; roseville CA 95747
• MDR Report Key: 11847882
• Report Number: MW5101407
• Device Sequence Number: 19925244
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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 Model Number: PNML6F088904
• Device Lot Number: H10661
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 138