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

Catalog Number PNML6F088904

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the neuron max 6f 088 long sheath (neuron max) was fractured approximately 3.0 cm from the hub and kinked approximately 47.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that it was fractured at the distal end of the strain relief.This damage may have occurred due to forceful handling of the neuron max during removal from the packaging.Further evaluation revealed the neuron max was kinked.This damage was likely incidental 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

While prepping a neuron max 6f 088 long sheath (neuron max) for the procedure, the physician noticed that the neuron max was split at the strain relief.The damaged neuron max was found prior to use and therefore, the neuron max 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: 6578734
• MDR Text Key: 75600560
• Report Number: 3005168196-2017-00777
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• 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: 04/21/2017

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: Physician
• Device Expiration Date: 11/23/2019
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F72239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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