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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Ischemia (1942); Perforation (2001)
Event Date 03/31/2021
Event Type  Death  
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.
 
Event Description
This is filed to report tissue damage, hypotension, hemorrhage, medical intervention, surgical intervention, delay and prolonged hospitalization. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. It was noted prolapsed posterior. The steerable guide catheter (sgc) was advanced to the mitral valve; however, the patient¿s blood pressure dropped. Medication was administered to raise the blood pressure. After the clip grasped the leaflets, the blood pressure dropped again. It was noted there was tension in the lower abdomen and suspected bleeding. The clip was deployed and mr was sufficiently reduced. However, the blood pressure did not stabilize after clip placement. Therefore, a blood transfusion was performed. After the blood pressure stabilized, angiography and computed tomography revealed a torn vein at the right femoral and iliac vein. The oxygen saturation was not good and the patient experienced acute respiratory distress syndrome (ards). Then the blood pressure dropped again and the patient continued to tension in the lower abdomen. This caused a clinically significant delay in the procedure as the patient was sent to surgery for additional treatment. One clip was implanted, reducing mr to 2. On 04/2/2021, the vein was surgically treated but the patient did not recover and died. 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 Key11688559
MDR Text Key246118490
Report Number2024168-2021-03267
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/11/2021
Device Catalogue NumberSGC0705
Device Lot Number01112U110
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 Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
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: 04/19/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER
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