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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
Catalog Number SGC0302
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional device referenced is being filed under a separate medwatch report.
 
Event Description
This is filed to report a broken hemostasis valve. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. Prior to the procedure, it was noted that the patient had very friable leaflets. The clip delivery system (cds) (91205u230) was inserted into the steerable guide catheter (sgc) (00213u344), but it was noticed that the sgc was facing in a posterior direction, but the clip was positioned in the anterior direction. This caused the sgc to be move in an abnormal direction. Therefore, the cds was attempted to be removed, but during removal the clip became stuck on the hemostasis valve of the sgc. It was then noticed that the hemostasis valve was broken; therefore, the sgc was removed from the stabilizer and placed below the heart to prevent the insertion of air. The physician was then able to remove both the cds and sgc without further issues. It was noted that the difficulty removing the clip was caused by the cds. A new sgc was inserted and one clip was successfully implanted on the lateral side of a2p2. To further reduce mr, an additional clip (91105u165) was implanted medially of the first clip. A remaining jet was noticed; therefore, a third clip was inserted and implanted at a3p3. However, after the third clip was implanted, it was noticed that the second clip caused a tear on the posterior leaflet. No additional clips were implanted mr reduced to a grade of 2-3. There was no clinically significant delay in the procedure. 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 Key10385901
MDR Text Key202795461
Report Number2024168-2020-06647
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/11/2021
Device Catalogue NumberSGC0302
Device Lot Number00213U344
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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