CAROTID WALLSTENT 26606

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 2020-03-10 for CAROTID WALLSTENT 26606 manufactured by Boston Scientific Corporation.

Event Text Entries

[182737230] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[182737231] It was reported that partial deployment occurred. The target lesion was located in the carotid artery. After dilation was performed with a non-bsc balloon catheter, a 10. 0-24 carotid wallstent stent was advanced for treatment; however, only about 80% was deployed and the outer sheath got stuck. Since the stent could not be deployed while being stuck, the area of the stent that was already deployed and the guiding catheter was advanced over the deployed part of the stent for removal. The procedure was completed with another of the same device. There were no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02499
MDR Report Key9811759
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-13
Date Mfgr Received2020-02-17
Device Manufacturer Date2019-11-15
Date Added to Maude2020-03-10
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 StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAROTID WALLSTENT
Generic NameSTENT, CAROTID
Product CodeNIM
Date Received2020-03-10
Returned To Mfg2020-03-03
Model Number26606
Catalog Number26606
Lot Number0024774934
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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