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

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician fractured the neuron max in the patient.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a non-penumbra sheath, an aspiration catheter and guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure while the physician attempted to advance an aspiration catheter over the neuron max, resistance was encountered.The physician decided to remove the neuron max and guidewire from the patient.Upon removal, the physician noticed the neuron max was kinked.It was also reported that although the neuron max was in the ica, the guidewire protruded through the damaged neuron max and into the subclavian artery.The procedure was completed using a new neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were updated on this follow-up #01 mfr report 3005168196-2023-00320: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Device code 1 and 2.Evaluation of the returned neuron max confirmed a kink and puncture at the kinked location.If the neuron max is advanced against resistance, damage such as a kink may occur.Subsequent attempt to advance an aspiration catheter with guidewire through a kinked catheter likely contributed to the catheter lumen puncture, and the guidewire exiting through the damaged location.The reported patient¿s tortuous anatomy may have contributed to the resistance during advancement.During evaluation a demonstration aspiration catheter could not advance past the kinked location on the neuron max.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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.H3 other text : placeholder.

• 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: 17263473
• Report Number: 3005168196-2023-00320
• Device Sequence Number: 7912303
• Product Code: DQY
• UDI-Device Identifier: 00815948022409
• UDI-Public: 815948022409
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023
• 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: 02/12/2026
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H00002138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005