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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCLARENT, INC RELIEVA SPIN; INSTRUMENT, ENT MANUAL SURGICAL
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ACCLARENT, INC RELIEVA SPIN; INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results
Model Number RS0616F
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2017
Event Type  malfunction  
Event Description
During the first balloon sinuplasty, the surgeon inserted the acclarent relieva spin balloon (6mm x 16mm, f-70, lot# 1507161), inflated the balloon once, deflated the balloon, repositioned it and reinflated the balloon again.The balloon failed/ruptured on the reinflation and was removed and replaced with a second balloon that worked without incident.No patient harm.
 
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Brand Name
RELIEVA SPIN
Type of Device
INSTRUMENT, ENT MANUAL SURGICAL
Manufacturer (Section D)
ACCLARENT, INC
33 technology dr.
irvine CA 92618
MDR Report Key6753488
MDR Text Key81378734
Report Number6753488
Device Sequence Number1
Product Code LRC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/16/2018
Device Model NumberRS0616F
Device Catalogue NumberRS0616F
Device Lot Number150716
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer07/28/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NONE THAT CONTRIBUTED TO THE EVENT.
Patient Age29 YR
Patient Weight80
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