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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); Positioning Failure (1158); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report a cable break and unable to straighten. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4. The steerable guide catheter (sgc) was prepared per the instructions for use (ifu); therefore, it was inserted into the anatomy. While the sgc was in the anatomy, the physician applied minus knob, but a click sound was heard. Therefore, the physician decided to remove the sgc. Once the sgc was removed from the anatomy, it was noted that the minus knob no longer worked and the sgc was unable to straighten. It was suspected that a cable break had occurred. The sgc was replaced and one clip was successfully implanted, reducing mr to a grade of 1. There were no adverse patient effects and 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 Key10706246
MDR Text Key212174203
Report Number2024168-2020-08734
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 12/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2021
Device Catalogue NumberSGC0302
Device Lot Number00413U258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2020
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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