EQUALIZER 20280

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-23 for EQUALIZER 20280 manufactured by Boston Scientific Corporation.

Event Text Entries

[184461680] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[184461681] It was reported that balloon deflation failure occurred. The target lesion was located in severely tortuous aorta-iliac. During the procedure, an equalizer 33/7/2/100 balloon catheter was advanced for dilatation. After the stent graft was placed, touch-up was performed without a problem from the aorta to the leg from the left side femoral. Next, after dilation was performed, when touch-up was performed from the right side femoral with the use of the same balloon, negative pressure was applied, but deflation could not be performed. The 20cc syringe was changed to 10cc syringe in first inflation and was able to perform the deflation slowly for four to five minutes manually and saline contrast ratio was approximately 50:50. This was attempted three times using the same size, 33mm, and 27mm all had the same issue. Eventually, touch-up was performed using gores coda balloon and was able to deflate with no resistance felt. The cause was not confirmed since the blood vessel was relatively straight anatomically. Moreover, there should be no resistance felt since the sheath was for stent graft and the lumen was thick. The procedure was completed with another of same device. There were no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03687
MDR Report Key9865323
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2020-01-01
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetMODEL FARM ROAD
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUALIZER
Generic NameCATHETER, PERCUTANEOUS
Product CodeMJN
Date Received2020-03-23
Model Number20280
Catalog Number20280
Lot Number0024973772
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
112 2020-03-23

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