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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 Arrhythmia (1721); Cardiac Arrest (1762); Pericardial Effusion (3271)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Based on the available information, a cause for the pericardial effusion, arrhythmia, and cardiac arrest could not be determined. The reported patient effects of pericardial effusion, arrhythmia, and cardiac arrest are listed in the mitraclip system instructions for use and are known possible complication associated with mitraclip procedures. The reported additional therapy/non-surgical treatments were a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design, or labeling.
 
Event Description
This is filed to report the pericardial effusion. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade 4. Transseptal access was obtained but was lost while introducing the guide into the patient. The dilator was removed from the steerable guide catheter (sgc) while the sgc was positioned in the right atrium. A catheter and wire combination were introduced in order to access the transseptal hole previously made. An angled glide wire crossed the original transseptal access, the catheter advanced through the septum, exchanged the glide wire for an amplatzer wire, removed the catheter, reinserted the dilator and advanced the guide across the septum. After removing the dilator and guide wire, the clip delivery system (cds) was inserted and steered down to the valve. After the clip was seen to be perpendicular to the mitral valve, it was discovered that the patient had a large effusion. The teamed prepared to perform a pericardiocentesis. While one physician was trying to access the pericardium, the patient went asystolic, the physician started cardiopulmonary resuscitation (cpr), and patient¿s rhythm came back within about 2 minutes and pericardiocentesis was completed. Once the blood was pulled from the pericardium, the mitraclip procedure continued. One clip was implanted reducing mr to 1. It is reportedly unclear what caused the effusion, possibly the sgc. The transseptal access was not located too posteriorly as to be the cause of the effusion. 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 Key10829357
MDR Text Key215971693
Report Number2024168-2020-09428
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
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/27/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00728U138
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 Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2020
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: 11/12/2020 Patient Sequence Number: 1
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