MAUDE Adverse Event Report: ARTHROCARE CORPORATION VENTERA SINUS DILATION BALLOON, 1-PACK; BALLOON, EPISTAXIS

Catalog Number 650-60100S

Device Problem Break (1069)

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

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported that during a sinus procedure using the ventera sinus dilation balloon, the balloon popped mid procedure and would no longer hold air.The procedure was stopped and could not be completed as there was no backup device available.No further details were provided regarding a follow up procedure.

• Brand Name: VENTERA SINUS DILATION BALLOON, 1-PACK
• Type of Device: BALLOON, EPISTAXIS
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; 7000 w william cannon dr; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr, bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4219011
• MDR Text Key: 4997981
• Report Number: 3006524618-2014-00240
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 650-60100S
• Device Lot Number: 101046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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
• Treatment: 950-10100 INFLATION DEVICE
• Patient Outcome(s): Other