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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Lot Number SP20B10-1427835
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
The reported product is an unknown baxter gem coupler. The device was not returned, and the lot number is invalid; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during the vessel loading process with a gem coupler, the plastic holder for the coupler split apart, further specified as "an entire arm of the coupler fell off¿. As a result, an excision of the vessel ends and use of a new coupler cartridge was required, which was reported as successful. It was reported the coupler was not handled with forceps. The event occurred on closing the arms of the couplers after the vessel ends had both been secured on the device. It was reported the white plastic piece did not break but remained attached to the broken arm of the coupler cartridge and was not able to be used to complete the anastomosis. The vessel ends remained everted on the coupler device; however, the coupler could not be approximated for anastomosis. Subsequently, the vessel ends were removed from the coupler, trimmed, and a new coupler was used, and no issues were noted. The new coupler was successful in achieving anastomoses, with stress and surgical time increased. No additional information is available.
 
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Brand NameNI
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 
2242702068
MDR Report Key12609039
MDR Text Key276112830
Report Number1416980-2021-06182
Device Sequence Number1
Product Code MVR
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberSP20B10-1427835
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1
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