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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 Difficult or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Insert (1316); Product Quality Problem (1506); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the steerable guide catheter (sgc) tip was not deflecting. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. During preparation of the steerable guide catheter (sgc), it was the observed the +/- knob had to be rotated further to see the deflection of the tip (the tip responded later than usual). When attempting to insert the sgc into the femoral vein, resistance was felt, and the tip kinked significantly showing a dent on the outer surface. The sgc was removed and the +/- knob was tested; it looked like the tip was almost not responding/deflecting. A new sgc was used; one clip was implanted, reducing mr to 1-2. There were no adverse patient effects and no clinically significant delay during 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 Key10003575
MDR Text Key189227661
Report Number2024168-2020-03941
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 05/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2020
Device Catalogue NumberSGC0302
Device Lot Number91004U144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2019
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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