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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Catalog Number SGC0705
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional mitraclip device is filed under a separate medwatch report number.
 
Event Description
This is being filed to report the difficulty removing the clip delivery system into the steerable guide catheter. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was successfully placed without issue. A second clip delivery system (cds) was advanced into the left atrium (la) when a fluttering tissue was noted on the clip on echo. Heparin was administered, and an attempt was made to remove the cds, however, resistance was met with the steerable guide catheter (sgc). Troubleshooting was performed however the cds could still not be retracted. The physician then decided to continue the procedure with the cds, and it was advanced to the mitral valve and deployed. A white foreign substance was noted attached to the tip of the cds once the clip detached from the delivery catheter (dc). The cds was removed and the procedure completed with the mr reduced 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 NameG4 STEERABLE GUIDING CATHETER
Type of DeviceCATHETER, STEERABLE
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 Key10830216
MDR Text Key216370495
Report Number2024168-2020-09444
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K190167
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 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/17/2021
Device Catalogue NumberSGC0705
Device Lot Number00717U123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2020
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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