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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and without a device to analyze a cause for the reported leak could not be determined. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This report is being filed as a leak was observed during device use. It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr). The first mitraclip was deployed. After the clip delivery system was removed, a leak was noted on the handle of the steerable guide catheter (sgc). The leak was at the connection of the hemostatic valve and the handle. The procedure continued with the deployment of the second mitraclip. After the second cds was removed, the leak was more noticeable, but no air entered the patient and no air was seen in the device. The same sgc was used to complete the procedure as the leak did not interfere with the case. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10931062
MDR Text Key219166566
Report Number2024168-2020-10072
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number01006U134
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 Received11/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2020
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: 12/01/2020 Patient Sequence Number: 1
Treatment
2 MITRACLIPS
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