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

Catalog Number PNML6F088804M

Device Problems Break (1069); Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2015

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

During preparation for a neuroradiology procedure, the nurse found that the middle of the neuron max 6f 088 long sheath (neuron max) was broken upon removal from its packaging.The damaged neuron max was found prior to use and was not used for the procedure.The procedure continued using a new neuron max.

Manufacturer Narrative

Result: the neuron max 6f 088 long sheath (neuron max) was kinked approximately 34.0 cm from the hub.The packaging card that the neuron max was mounted on was not damaged.Conclusion: evaluation of the returned device confirmed that the neuron max was kinked.This type of damage typically occurs if the product was improperly handled during removal from the packaging.If the neuron max is removed from the packaging tube at an angle, the device may kink.These devices are 100% visually inspected for damage during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5300760
• MDR Text Key: 33589403
• Report Number: 3005168196-2015-01283
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F63519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2015
• 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