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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device was returned. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system listed is captured under a separate medwatch report.
 
Event Description
This is filed to report a torn soft tip of the steerable guide catheter (sgc) it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The clip delivery system (cds) was advanced and grasping was performed. However, the mitral valve was unable to be grasped; therefore, the decision was made to terminate the procedure. When retracting the cds, the clip became caught on the soft tip of the steerable guide catheter (sgc). Troubleshooting was performed, and the clip was freed from the sgc and was retracted without further issues. However, it was noted that a tear in the soft tip of the sgc occurred. The sgc was removed and mr remained at a grade of 4. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameSTEERABLE 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 Key9224574
MDR Text Key175907917
Report Number2024168-2019-12843
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 11/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/03/2020
Device Catalogue NumberSGC0302
Device Lot Number90502U152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2019
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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