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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 08/23/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other additional device referenced are being filed under a separate medwatch report number. Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period.
 
Event Description
This is being filed to report the tear in the sgc tip. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. The clip delivery system (cds) was advanced to the atrium and the arm positioner was rotated however the clip arms would not close. Troubleshooting was performed however was unsuccessful therefore the clip was inverted and the cds was attempted to be retracted through the steerable guide catheter (sgc). Resistance was met therefore force was applied, resulting in the tip of the sgc tearing. The cds and sgc were removed together. Another sgc and cds were used, and the clip was implanted, reducing the mr to 1. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key8989956
MDR Text Key157399076
Report Number2024168-2019-11674
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/10/2020
Device Catalogue NumberSGC0302
Device Lot Number90611U252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/11/2019 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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