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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 SGC0702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 10/21/2020
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 reported pericardial effusion could not be determined. The reported patient effect of pericardial effusion as listed in the mitraclip system instructions for use (ifu) is a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design, or labeling.
 
Event Description
This is being filed to report the pericardial effusion requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. During the procedure an increasing pericardial effusion was noted therefore the steerable guide catheter (sgc) and clip delivery system (cds) were removed and the procedure aborted with the mr remaining at 4. Pericardiocentesis was performed as treatment. The patient remained in stable condition. There was no clinically significant delay in the procedure and no adverse patient sequela. 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 Key10824451
MDR Text Key215905852
Report Number2024168-2020-09411
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/14/2021
Device Catalogue NumberSGC0702
Device Lot Number00814U238
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 Received10/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2020
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: 11/11/2020 Patient Sequence Number: 1
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