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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 Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2020
Event Type  malfunction  
Manufacturer Narrative
The returned device analysis observed a tear on the silicone valve and kink on steerable guide catheter (sgc) tip. A review of the lot history record revealed no manufacturing issued to the reported lot that would have contributed to the reported issue. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated, the reported tear on silicone valve and kink on sgc tip appear to be due to the user technique. There is no indication of a product issue with respect to manufacture, design or labeling. The additional mitraclip delivery system device is filed under a separate medwatch report number.
 
Event Description
This is being filed to report the damage to steerable guide catheter hemostasis valve. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4. The clip delivery system (cds) was inserted into the patient however it was not possible to steer down to the valve with the m knob. Several attempts were made however were unsuccessful therefore the cds was removed. The device was tested outside the anatomy and worked as intended therefore the cds was re-inserted however again failed to steer down to the valve. The cds was removed and the procedure aborted with the mr remaining at 3-4. There was no clinically significant delay in the procedure and no adverse patient effects. Return device analysis noted the clip cover was torn and the steerable guide catheter (sgc) soft tip was deformed and the silicone valve inside the hemostasis valve was torn. 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 Key10368029
MDR Text Key201872033
Report Number2024168-2020-06521
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
Report Date 08/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2021
Device Catalogue NumberSGC0302
Device Lot Number00218U217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
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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