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

Catalog Number PNML6F088904M

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the neuron max was fractured approximately 92.0 cm from the hub.Conclusions: evaluation of the neuron max revealed that the distal tip was fractured.This damage typically occurs due to improper handling during removal from the packaging.If the packaging mandrel slips out from the packaging tape, and the neuron max and packaging mandrel are forcefully withdrawn through the packaging tube, damage such as this may occur.Penumbra catheters are visually inspected during in-process inspection and during quality inspection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.

Event Description

During preparation for a medical procedure, the hospital staff noticed that the tip of a neuron max 6f 088 long sheath (neuron max) was ripped upon removal from the packaging.The damage to the neuron max was found prior to use.Therefore, the neuron max was not used in the procedure.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: 7517064
• MDR Text Key: 108355172
• Report Number: 3005168196-2018-00979
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2021
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F81801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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