SMALL PERIPHERAL CUTTING BALLOON 24658

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 2020-03-31 for SMALL PERIPHERAL CUTTING BALLOON 24658 manufactured by Boston Scientific Corporation.

Event Text Entries

[185941079] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[185941080] It was reported that balloon rupture occurred. The 100% stenosed target lesion was in a moderately tortuous and moderately calcified left superficial femoral artery. A 3. 50mm/1. 5cm/140cm small peripheral cutting balloon was selected for use. During procedure, it was noted that the balloon ruptured upon second inflation at 10atm for 3 seconds and was removed without any problem. The procedure was completed with another of the same device. No complications reported and there was no problem with the patient post procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-04167
MDR Report Key9908337
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2017-06-01
Date Added to Maude2020-03-31
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 IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMALL PERIPHERAL CUTTING BALLOON
Generic NameCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Product CodeNWX
Date Received2020-03-31
Model Number24658
Catalog Number24658
Lot Number0020714904
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
10 2020-03-31

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