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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Event Date 01/19/2022
Event Type  Injury  
Event Description
This will be filed to report during use of the steerable guide catheter (sgc), a pericardial effusion occurred requiring pericardiocentesis. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation. When the physician was advancing the sgc (with dilator) across the septum, the sgc was only visualized tenting at the septum. The sgc or dilator could not be visualized in the left atrium so the physician kept advancing the sgc. The imager continued trying to visualize the sgc at the septum and the left atrium, but when visualization was captured of the sgc in the left atrium, it was almost to the left atrial wall. The clip delivery system was advanced and when grasping was performed without issue, the patient's blood pressure dropped, and a pericardial effusion was noted. Medication was given by the anesthesiologist. The clip was able to be implanted, reducing mr to 2. Then, pericardiocentesis was performed. The physician suspects that the sgc (with dilator inside) was advanced too far into the la, likely contacted & injured the atrial wall. The next day, the patient experienced some chest pain and had some ekg changes. A heart catheterization procedure was performed to see if the patient had any acute coronary artery blockages. They did not find any acute issue that warranted further intervention. The clip remained stable and there was no tissue damage noted. It is unknown if these were a result of the effusion. The patient had computerized tomography (ct) which showed no pulmonary embolism. On (b)(6) 2022, the patient was noted to be stable. No additional information was provided.
 
Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system referenced is filed under a separate medwatch report number.
 
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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 Key13472499
MDR Text Key285182548
Report Number2024168-2022-01229
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10621R159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2021
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: 02/07/2022 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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