ANGIOJET SOLENT OMNI THROMBECTOMY SET 109681-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for ANGIOJET SOLENT OMNI THROMBECTOMY SET 109681-001 manufactured by Boston Scientific Corporation.

Event Text Entries

[182701334] Tubing failed to prime. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093575
MDR Report Key9800695
Date Received2020-03-05
Date of Report2020-03-04
Date of Event2020-03-03
Date Added to Maude2020-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANGIOJET SOLENT OMNI THROMBECTOMY SET
Generic NameCATHETER, EMBOLECTOMY
Product CodeDXE
Date Received2020-03-05
Catalog Number109681-001
Lot Number25101211
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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