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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 Unintended Movement (3026)
Patient Problem Perforation (2001)
Event Date 11/12/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other two devices referenced are filed under separate medwatch report numbers.
 
Event Description
This is filed to report the atrial septal defect. Patient id: (b)(6). It was reported the mitraclip procedure was performed to treat grade 4 degenerative mitral regurgitation. The mean pressure gradient was 6mmhg. When inserting the mitraclip delivery system (cds) (10612r275), into the steerable guide catheter (sgc), the stabilizer was pulled too much and the sgc slipped from the left atrium to the right atrium. When removing the cds to try to approach the left atrium again, the clip got caught on the clip introducer (ci). A scratch was observed on the ci due to the interference with the gripper arm. A new ci and cds were used. Two clips were implanted without issue. A third clip (10324r249) was advanced to further reduce mr. During deployment, when pulling the actuator knob, the cds jumped due to stored torque and the clip detached from one leaflet and remained attached to the other leaflet (single leaflet device attachment/slda). Mr increased to 2+. No additional clips were implanted because the mean pressure gradient was already at 7mmhg. On (b)(6) 2021, prior to discharging the patient, echocardiogram revealed mr increased to 4+. The mr likely increased due to twisting surrounding valve leaflets because of the slda. The patient¿s condition was poor, due to the atrial septal defect and the worsened mitral stenosis. Medication was given to improve hemodynamics and increase blood pressure. Mitral valve replacement was performed on (b)(6) 2021. It is unknown if the steerable guide catheter worsened the fragile septum, resulting in a worsened atrial septal defect; however, the physician thinks the tissue was fragile because the needle was easily pulled out when the interatrial septum was punctured during the mitraclip procedure. The atrial septal defect was surgically treated. 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 Key13044665
MDR Text Key285183124
Report Number2024168-2021-11903
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 Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0705
Device Lot Number10512R122
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2021
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: 12/20/2021 Patient Sequence Number: 1
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