WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3851

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 WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3851 manufactured by Boston Scientific Corporation.

Event Text Entries

[185940711] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[185940712] It was reported that the balloon ruptured. The 90% stenosed target lesion was located in the mildly tortuous and severely calcified vessel. A 10mm x 3. 00mm wolverine coronary cutting balloon was selected for use. During the procedure, the balloon was inflated at 6atm and 8atm. However, the balloon ruptured upon third inflation at 10atm and was removed from the patient's body 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. Per physician's comment, the balloon ruptured due to calcification.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-04164
MDR Report Key9908346
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 Date2019-12-03
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 NameWOLVERINE CORONARY CUTTING BALLOON MONORAIL
Generic NameCATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Product CodeNWX
Date Received2020-03-31
Model Number3851
Catalog Number3851
Lot Number0024863302
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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