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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR

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BAXTER HEALTHCARE CORPORATION COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Catalog Number 5111-00250-060
Device Problem Disconnection (1171)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that ¿the coupler portion (2. 5mm coupler) fell out of coupler device¿; this was further described as ¿when they picked it up to prepare for implantation the one ring on the coupler where the vessel is attached fell off¿. This occurred during set up prior to use on the patient. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The actual sample was received for evaluation. The jaw assembly was returned free floating in the outer tray from the packaging. One ring was intact remaining in the right jaw of the assembly and the other ring was not returned. There were no signs of use on the one coupler ring that was in the jaw assembly returned for investigation. The reported condition was verified. The cause of the condition was not determined. A functional testing was not performed for this complaint. A device history review revealed no issues that could have caused or contributed to the reported issue. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCOUPLER
Type of DeviceDEVICE, ANASTOMOTIC, MICROVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
SYNOVIS SURGICAL INNOVATIONS
2575 university ave w
saint paul MN 55114
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9538618
MDR Text Key173340841
Report Number1416980-2019-07294
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5111-00250-060
Device Lot NumberSP19J29-1405751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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