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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLO-THRU CLAMP, VASCULAR

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BAXTER HEALTHCARE CORPORATION FLO-THRU CLAMP, VASCULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported from an anonymous survey result that the potential response risk with the use of a flo-thru intraluminal shunt when used to channel (shunt) intravascular blood through a vascular anastomosis to provide a temporary blood free operative field, during coronary artery procedures was rated as moderate for risk of disruption of plaque and subintimal dissection. The physician reported ¿if there is a soft or calcified plaque near the arteriotomy, placing or removing the shunt can sometimes loosen the plaque¿ and ¿insertion of the shunt can occasionally disrupt the edge of the intima at the arteriotomy if i oversize the shunt for the vessel lumen" (no further details). At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome. No additional information is available.
 
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Brand NameFLO-THRU
Type of DeviceCLAMP, VASCULAR
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 Key10543623
MDR Text Key207290933
Report Number1416980-2020-05757
Device Sequence Number1
Product Code DXC
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/16/2020 Patient Sequence Number: 1
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