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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN BALLOON SINUPLASTY SYSTEM SINUS BALLOON CATHETER

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ACCLARENT, INC. RELIEVA SPIN BALLOON SINUPLASTY SYSTEM SINUS BALLOON CATHETER Back to Search Results
Catalog Number RS0616M
Device Problem Material Rupture
Event Date 06/20/2014
Event Type  Malfunction  
Event Description

Acclarent was informed of an event wherein the balloon ruptured when the physician was dilating the maxillary sinus. The physician replaced the device and completed the procedure with no reported patient injury. Acclarent received the spin sinuplasty balloon catheter device on (b)(6) 2014 and investigation was completed on (b)(6) 2014. Acclarent noticed that the balloon was missing from the catheter upon receipt.

 
Manufacturer Narrative

The initial complaint did not include information to indicate the balloon was missing from the catheter. The device evaluation performed upon receipt of the device confirmed the balloon was missing from the catheter. A follow up to the facility was conducted inquiring the location of the missing balloon. The user facility responded that the location of the missing balloon. The user facility responded that the location of the missing balloon is unknown. There was no reported patient injury. Acclarent will continue to monitor this phenomenon for trending purposes.

 
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Brand NameRELIEVA SPIN BALLOON SINUPLASTY SYSTEM
Type of DeviceSINUS BALLOON CATHETER
Manufacturer (Section D)
ACCLARENT, INC.
menlo park CA
Manufacturer Contact
izabel nielson, sr. mgr
1525-b o'brien dr.
menlo park , CA 94025
6506874924
MDR Report Key4109639
Report Number3005172759-2014-00023
Device Sequence Number1
Product CodeLRC
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/19/2017
Device Catalogue NumberRS0616M
Device LOT Number140319B-CM
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/11/2014
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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