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

Model Number	PNML6F088904M
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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 medical procedure in the middle cerebral artery (mca) to treat an arteriovenous malformation (avm) using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance while inserting a dilator into a neuron max and decided to remove the neuron max.Upon removal, it was noticed that the neuron max was stretched at the distal end and kinked at the proximal end.The procedure was completed using a non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max confirmed that the catheter was stretched.If the neuron max is forcefully retracted against resistance, damage such as stretching may occur.Further evaluation revealed a kink in the proximal shaft.This damage was incidental to the reported complaint and the root cause could not be determined.During the functional test, the dilator was able to be advanced through the neuron max with resistance due to the kink and stretching on the catheter shaft.Penumbra catheters are visually 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.

• 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: 12303684
• Report Number: 3005168196-2021-01783
• Device Sequence Number: 19826200
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• 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,Followup
• Report Date (Section B): 09/08/2021
• 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: 10/19/2023
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H10831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005