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

Catalog Number PNML6F088904M

Device Problems Break (1069); Material Puncture/Hole (1504); Material Deformation (2976)

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

Event Date 06/08/2023

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 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 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.

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
• 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: 17263473
• MDR Text Key: 318500062
• Report Number: 3005168196-2023-00320
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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 Sex: Female