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

Model Number	PNML6F088804M
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the common carotid artery (cca) and internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max), an embolic protection system, and a stent device.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the embolic protection system through the neuron max to the target vessel.The physician then advanced the stent delivery system over the guidewire of the embolic protection system and through the neuron max to the target vessel.Next, the physician deployed the stent device in the target location and then removed the embolic protection system and stent delivery system.Subsequently, the physician experienced resistance while removing the neuron max and upon removal the physician noticed that the distal end of the neuron max was damaged.It was reported that the outer layer of the distal end of the neuron max was damaged and that the inner braiding of the neuron max was exposed.A subsequent angiography showed that no damaged piece of the neuron max was left in the patient.The procedure ended at this point.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 at the distal segment.Evaluation revealed fractures and exposed braided material at the stretched location.If the neuron max is inadvertently retracted against resistance, damage such as stretching and subsequent fractures may occur.The root cause of resistance during the procedure could not be determined.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15602756
• Report Number: 3005168196-2022-00473
• Device Sequence Number: 14035502
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2022
• 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: 04/30/2022
• Device Model Number: PNML6F088804M
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F90005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• 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: 09/19/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• 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: 43 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005