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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 SGC0704
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation as it was reportedly discarded. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The mitraclips, are filed under separate medwatch report numbers.
 
Event Description
This report is being filed due to a clinically significant atrial septal defect requiring surgical intervention. Patient id: (b)(6). It was reported that on (b)(6) 2021, a mitraclip procedure was performed to treat degenerative mitral regurgitation (dmr) grade of 4+ with p2 leaflet prolapse and a p2 flail. The p2 leaflet was redundant. Two xtw mitraclips were delivered and deployed on the a2p2 leaflets. Reportedly, both these clips rotated after deployment, while remaining stable on the leaflets. An ntw mitraclip advanced to the mitral valve with noted difficult visualization due to the anatomy and anatomy being so commissural. The mitraclip was having difficulty grasping the leaflets and was unable to capture leaflets. It was decided to remove this clip. During cds removal, some resistance was met with the anatomy. Standard troubleshooting was performed with successful removal following. Reportedly, during the removal, chordal rupture was possible as there was new flail or anterior prolapse that was not present before the procedure. Another xtw mitraclip was successfully delivered and deployed on the a1p1 leaflets. This clip was the most lateral clip. There was no detachment observed post the index procedure. The mr was reduced to 1-2+. There was no clinically significant delay in the procedure. There was no device issue or malfunction regarding the implanted xtw clips. On (b)(6) 2021 the patient was readmitted to the hospital due to dyspnea, chest tightness, and worsening heart failure was diagnosed. Medications had been provided as treatment. Per imaging, severe mr, mitral stenosis, and chordal damage were observed. The pulmonary artery (pa) pressures were noted elevated. Reportedly, there was no concern regarding the implanted xtw mitraclips. These clips had remained well seated without any device malfunction. However, per physician, there was a flail chord or flail leaflet at the a1p1 area that was not identified during or after the initial procedure. The a1 had torn off the annulus from the most lateral clip. This clip was subvalvular. The physician believes that the patient "popped a chord" causing the severe mr to return. The popped chordae associated with the third clip was that one of the chordae tore off the sub-valvular area and a new flail was noted in the atrium due to this. The chordae was still attached to the ventricular area. On (b)(6) 2021 the three mitraclips were successfully explanted and valve replacement was performed as treatment. An atrial septal defect closure, tricuspid repair, and left atrial appendage ligation were also performed. Non-abbott physio rings were placed in the valves. The mr had been reduced to grade 1+. Reportedly, the tricuspid repair was unrelated to the mitraclip devices and unrelated to the mitraclip procedure. No additional information was provided regarding this issue.
 
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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 Key12499915
MDR Text Key273552509
Report Number2024168-2021-08308
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 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/10/2021
Device Catalogue NumberSGC0704
Device Lot Number01110U134
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 Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
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: 09/20/2021 Patient Sequence Number: 1
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