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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 SGC0301
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
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. The customer reported the device was discarded. A follow-up report will be submitted with all additional relevant information. The clip referenced is being filed under a separate medwatch report.
 
Event Description
This is filed to report during withdrawal of the cds, the clip got caught with the sgc tip and damaged the soft tip. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. Two clips implanted successfully, reducing mr to 2. A third clip delivery system (cds) was advanced to the mitral valve to further reduce mr. The clip was placed but mr reduction was not adequate for the clip to be used. Therefore, it was decided to not deploy the clip, the clip was closed and retracted into the steerable guide catheter (sgc). However, the clip arms got caught with sgc tip. The cds was advanced to left atrium and the clip was rotated. The clip was able to be retracted into the sgc, but the sgcs tip was damaged (torn). There were no other issues with the devices. Both cds and sgc were removed from the patients anatomy successfully. Two clips implanted, reducing mr to 2. There was no adverse patient effect 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
connie speck
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8790581
MDR Text Key151130563
Report Number2024168-2019-10076
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/24/2020
Device Catalogue NumberSGC0301
Device Lot Number90424U119
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 Received08/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2019
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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