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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 SGC0702
Device Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 12/16/2020
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. The xt clip referenced was filed under medwatch report number 2024168-2021-00122-00 and the nt clip referenced was filed under 2024168-2021-00125-00.
 
Event Description
This is filed to report a tear in the silicone valve of the sgc. It was reported that the index mitraclip procedure was performed on (b)(6) 2012 to treat functional mitral regurgitation (mr) with grade 4. One clip was implanted, reducing mr 2. On (b)(6) 2020, a procedure was performed to treat normal development of the disease, mr jets in the medial and lateral position of the previous clip implanted in 2012. The first clip was implanted without problems and leaflet insertion assessment was performed per the instruction for use (ifu). After a couple of minutes, the clip appeared to have a single leaflet device attachment (slda). The clip had detached from the posterior leaflet. It was decided to implant another clip medial to solve the medial jet. The clip was placed and during deployment sequence, the lock line was pulled out approximately 25 cm and would not retract any further. The lock line did not work. Therefore, it was decided to deploy the clip and remove the lock line as part of the deployment. During this maneuver, the clip was opened and inverted, and it was decided to remove the clip to avoid embolism of the clip. A vascular surgeon was required to remove the clip from the vein. Mr remained the same. The patient remained stable and was recovering from the minimal vascular intervention. Device analysis of the returned steerable guide catheter found that the silicone valve was torn and flush port was broken. Additional information reported that the valve damage was due to the clip being extracted by the physician at the end of the procedure. 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 Key11293667
MDR Text Key232188180
Report Number2024168-2021-00941
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
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 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2021
Device Catalogue NumberSGC0702
Device Lot Number00902U151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2020
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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