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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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 05/19/2021
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 this event. Based on the available information, causes for the hypotension and bradycardia could not be determined. Additionally, hypotension and bradycardia are listed in the instructions for use as known possible complications associated with mitraclip procedures. The reported medication required, delay to treatment and unexpected medical intervention were the results of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design, or labeling. The additional mitraclip device referenced is filed under separate medwatch report number.
 
Event Description
This is filed to report bradycardia. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. Patient had a pericardial effusion, low heartbeat and had been on an intra-aortic balloon pump (iabp) for several days prior to the procedure. The steerable guide catheter (sgc) was inserted and advanced into the left atrium (la) without issues. However, roughly 3-5 minutes after the sgc reached the la, the patient blood pressure decreased, and bradycardia occurred. Chest compressions were performed, and adrenaline was administered, resulting in a clinically significant delay in the procedure. The patient was able to be stabilized; therefore, the physician decided to continue with the procedure. An ntw clip was inserted and grasping was performed at a2/p2. After the leaflets were grasped, regurgitation was observed on the proximal part of the clip. It was suspected that the clip had caused damage to leaflets; therefore, the clip was removed and replaced with an xtw clip. This clip was successfully implanted, reducing mr to a grade of 1. There was no clinically significant delay in the procedure. 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 Key11984373
MDR Text Key255773660
Report Number2024168-2021-04926
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
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/08/2022
Device Catalogue NumberSGC0705
Device Lot Number10109U151
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 Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2021
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: 06/11/2021 Patient Sequence Number: 1
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