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); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the neuron max distal tip did not show evidence of damage.The neuron max was fractured approximately 3.0 cm from the hub and was kinked approximately 83.0 cm from the hub.Conclusions: evaluation of the returned neuron max revealed a device with an undamaged distal atraumatic tip.The neuron max tip was compared with a demonstration device and were indistinguishable from each other.Further evaluation revealed that the neuron max was kinked and fractured.If the neuron max is forcefully manipulated at extreme angles when removed from packaging or otherwise mishandled during preparation, the device may become fractured.Based on the return condition, the kink was likely incidental to the reported failure and may have occurred due to the packaging for return to penumbra.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 found that a neuron max 6f 088 long sheath (neuron max) had a tear at the distal tip upon removal from the packaging.The damaged neuron max was found prior to use, and therefore, was not used in the procedure.The procedure was completed using another neuron max.

• 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: 7612320
• MDR Text Key: 111701144
• Report Number: 3005168196-2018-01210
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/22/2021
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F82504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• 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