MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT 6F CATHETER; DQY

Catalog Number PNS6F125SIM

Device Problems Out-Of-Box Failure (2311); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2015-01324.

Event Description

During preparation for a medical procedure, the hospital staff found that the tip shapes of two neuron select 6f catheters (6f select) did not correspond to the correct shape on the labeling.The two 6f select devices with incorrect tip shapes were found prior to use and were not used for the procedure.The procedure continued using another manufacturer's catheter.

Manufacturer Narrative

Corrected from "no: device evaluation anticipated, but not yet begun" to no: other ¿ the device is no longer available for return.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: NEURON SELECT 6F 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: 5322999
• MDR Text Key: 34277780
• Report Number: 3005168196-2015-01325
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012070
• UDI-Public: 00814548012070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070970
• 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,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PNS6F125SIM
• Device Lot Number: F46692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2014
• 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