MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 088 DELIVERY CATHETER; DQY

Catalog Number PNML6F088904M

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a medical procedure using a neuron max 088 delivery catheter (neuron max).While advancing the neuron max to the aneurysm, the marker band of the neuron max fractured and migrated to the patient's lung.There was no attempt to retrieve the marker band.The procedure successfully continued using a new neuron max.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the neuron max 088 (neuron max) was kinked approximately 30.0 cm and 43.5 cm from the hub.The distal tip extrusion of the neuron max was skived off to confirm the missing marker band.Conclusion: evaluation of the returned neuron max confirmed a detached marker band.Although the tip of the catheter showed no damage, the marker band was not present in the expected location of the distal tip.The cause of this issue is unknown but will be closely monitored.All of the manufacturing records for the device were reviewed and no issues were noted during product processing or inspection.The catheters are 100% visually inspected for damage during processing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: NEURON MAX 088 DELIVERY CATHETER
• 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: 5089052
• MDR Text Key: 26255248
• Report Number: 3005168196-2015-00916
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F61447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• 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
• Patient Age: 55 YR