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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
Model Number SGC0701
Device Problem Difficult to Remove (1528)
Patient Problem Atrial Perforation (2511)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
The clip remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The two additional devices referenced are filed under separate medwatch report numbers.
 
Event Description
This is being filed to report the difficulty removing the clip delivery system (cds) and atrial perforation. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. Although imaging was difficult due to device shadowing, the ntw clip was implanted. Shortly after deployment of the ntw clip, it was noted the clip mobility changed as the clip had detached from the posterior leaflet (single leaflet device attachment (slda)). A second clip was implanted to stabilize the slda clip. A third clip delivery system (cds) was advanced to be placed lateral to the slda clip however during placement and steering/alignment of the cds, a loss of height and subsequent lack of support of the steerable guide catheter (sgc) was noted. It was determined that the inter-atrial septum tore with significant right to left shunting of blood. Because of this new complication, the physician was forced to use situational steering to attempt to restore height and properly align the device. After grasping the leaflets, the gradient increased therefore the clip was not implanted. The third clip was closed and properly aligned to retract into the sgc. As the physician retracted the cds, the radiopaque ring stopped at the sgc radiopaque marker and would not allow the clip to be fully retracted. Several attempts were made to retract the cds without success. The decision was made to withdrawal the sgc and closed clip into the right atrium (ra) and the inferior vena cava (ivc). There, the physician attempted again to withdrawal the clip into the sgc when abruptly the mandrel and l lock separated from the clip causing the clip to invert with the lock line still attached. The system was retracted further to attempt to snare the device; however the clip was retracted too far and into the subcutaneous tissue making the possibility to snare the clip unachievable. Because of the extra vascular location of the clip, the physician decided to consult with vascular surgery. Vascular surgery assessed the patient and successfully removed the device from the patient¿s right common femoral region. The procedure was completed with the mr reduced to 3-4. The torn septum was treated with an occluder device. 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 Key10837468
MDR Text Key216173686
Report Number2024168-2020-09507
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
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 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00826U217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2020
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: 11/13/2020 Patient Sequence Number: 1
Treatment
2 IMPLANTED MITRACLIPS; CLIP DELIVERY SYSTEM
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