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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 03/09/2022
Event Type  Injury  
Event Description
This is filed to report pericardial effusion, prolonged hospitalization and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation with a grade of 4+. The steerable guide catheter (sgc) was advanced to the mitral valve, and one clip was successfully deployed, reducing mr to 1. Later on after the procedure ended, a mild pericardial effusion (pe) was observed. Then the patient's blood pressure dropped and imaging confirmed that the pe had increased in size. Therefore, the patient remained hospitalized longer and pericardiocentesis was performed. The patient is stable and was transferred to a post holding unit for observation. The patient no longer has a pe. The physician stated that the sgc may have caused the pe. No other information was provided.
 
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 available information, a cause of the reported pericardial effusion could not be determined. The reported hypotension was a secondary effect of the reported pericardial effusion. The reported patient effect of pericardial effusion and hypotension as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures. The reported unexpected medical intervention and hospitalization were results of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key13966680
MDR Text Key288299090
Report Number2024168-2022-03400
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
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10922R443
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2021
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: 03/31/2022 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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