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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 03/17/2022
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 additional devices are filed under separate medwatch report numbers.
 
Event Description
This will be filed. It was reported there was an atrial septal defect requiring intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip (11014r315) was successfully implanted on the medial part of the valve, a second clip (11123r374) was successfully implanted medially to the first. A third clip (10823r263) was implanted in the center of the valve. After deploying the third clip a laceration was noted on the anterior leaflet at the level of the second clip, and it was observed that the second clip had detached from the anterior leaflet and remained on the posterior leaflet (single leaflet device attachment (slda)). A fourth clip (11116r282) was positioned medially to the second clip, after a few grasping attempts it was noted that the first clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda). The fourth clip was successfully implanted stabilizing the first and second clip. The mr remained at a grade of 4. Following removal of the steerable guide catheter (sgc) shunt flow was noted between the right and left atrium and an atrial septal occluder was implanted eliminating the flow. There was no clinically significant delay in the procedure and no adverse patient sequela. 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 Key14073986
MDR Text Key288994634
Report Number2024168-2022-03846
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number11028R252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2021
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: 04/11/2022 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP(X3); STEERABLE GUIDE CATHETER
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