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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 Difficult to Advance (2920)
Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Date 02/17/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report tissue damage, hemorrhage and a fistula. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. The steerable guide catheter (sgc) was inserted, but the physician felt resistance during advancement. The sgc was able to reach the left atrium; therefore, the clip delivery system (cds) was inserted. The clip was successfully deployed, reducing mr to a grade of 1. While removing the devices, a cut on the artery was observed, causing a bleed. The physician stated that during insertion, the sgc may have scraped an artery, causing a fistula. However, this was unable to be confirmed. The bleed was successfully treated with a balloon, and the patient was noted to be stable. No additional information was 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 Key11454443
MDR Text Key238921578
Report Number2024168-2021-01904
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,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00622U237
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 Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2020
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: 03/10/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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