COUPLER 511100250010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-03 for COUPLER 511100250010 manufactured by Synovis Surgical Innovations.

Event Text Entries

[150016788] (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[150016789] It was reported that a patient underwent a radial forearm free-flap for head and neck reconstruction surgery in which a 2. 5mm coupler device was used. It was reported after deployment, the anastomosis? Bled/ leaked? Which resulted in removal of the coupler device. A new coupler? Of the same size? Was used and no additional issues were reported as a result of the explant and reapplication of a new coupler. It was reported the patient was? Doing great?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2019-03605
MDR Report Key8760552
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-07-03
Date of Report2019-10-29
Date of Event2019-05-21
Date Mfgr Received2019-10-24
Date Added to Maude2019-07-03
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1SYNOVIS SURGICAL INNOVATIONS
Manufacturer Street2575 UNIVERSITY AVE. W
Manufacturer CitySAINT PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal Code55144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUPLER
Generic NameDEVICE, ANASTOMOTIC, MICROVASCULAR
Product CodeMVR
Date Received2019-07-03
Model NumberNA
Catalog Number511100250010
Lot NumberSP19D17-1367451
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNOVIS SURGICAL INNOVATIONS
Manufacturer AddressSAINT PAUL MN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-03

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