COUPLER 511100200010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-08 for COUPLER 511100200010 manufactured by Baxter Healthcare - Saint Paul - Mca.

Event Text Entries

[135530693] C jaloux, b. Betrand, a. Mayoly, m. Cegarra-escolano, c. Philandrianos. Microvascular anastomotic coupler: an unexpected adverse event, thieme e-journals-journal of reconstructive microsurgery/abstract, oculoplastic surgery, third edition, https://www. Thieme-connect. De/media/irm/efirst/lookinside/10-1055-s-0038-1677036-180263-1. Ipg. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[135530694] It was reported that a patient underwent a revision surgery to remove a 2. 0mm coupler device which was used for an anastomosis between the anterolateral thigh (alt) pedicle veins and the dorsalis pedis veins. It was reported approximately nine months after the initial surgery, the patient complained of a small discomfort in the dorsum of the operated foot. An x-ray was performed which confirmed the device underneath the skin. The revision surgery removed the device and the artery was left anastomosed. It was reported there were no complications after the procedure. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[140060465] The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[140060466]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2019-00667
MDR Report Key8320639
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-02-08
Date of Report2019-03-07
Date Mfgr Received2019-02-28
Date Added to Maude2019-02-08
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 G1BAXTER HEALTHCARE - SAINT PAUL - MCA
Manufacturer Street2575 UNIVERSITY AVE W
Manufacturer CitySAINT PAUL MN 55114
Manufacturer CountryUS
Manufacturer Postal Code55114
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUPLER
Generic NameDEVICE, ANASTOMOTIC, MICROVASCULAR
Product CodeMVR
Date Received2019-02-08
Model NumberNA
Catalog Number511100200010
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - SAINT PAUL - MCA
Manufacturer AddressSAINT PAUL MN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-02-08

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