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

Catalog Number PNML6F088804

Device Problems Break (1069); Unraveled Material (1664)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned neuron max confirmed that the catheter was fractured, and the internal coil winds were unraveled at the hub.Evaluation revealed that the device was kinked at the id band and, upon inspection, was confirmed to be the location of the fracture.If the hub of the neuron max is torqued during manipulation of the device within the reported patient¿s tortuous anatomy, damage such as a kink and subsequent fracture may occur.Further evaluation revealed a kink and ovalization on the device.This damage was likely incidental to the reported complaint and likely occurred during packaging for return to penumbra.Penumbra catheters are 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.

Event Description

The patient was undergoing a medical procedure using a neuron max 6f 088 long sheath (neuron max).It was noted that the patient¿s anatomy was tortuous.During the procedure, while injecting contrast through the neuron max, the physician noticed the neuron max had unraveled at the hub.Therefore, the neuron max was removed.The procedure was completed using a new neuron max.There was no report of an adverse effect to the patient.

• 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: 17195042
• MDR Text Key: 317955294
• Report Number: 3005168196-2023-00297
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815948022379
• UDI-Public: 815948022379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: PNML6F088804
• Device Lot Number: H00002231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• 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
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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