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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 Respiratory Distress (2045); Atrial Perforation (2511)
Event Date 11/06/2020
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, the reported atrial perforation appears to be due to procedural conditions. Additionally, the reported respiratory distress was a cascading event of the atrial perforation. The reported patient effects of atrial perforation and respiratory distress are listed in the mitraclip system instructions for use, and are known possible complications associated with mitraclip procedures. The reported additional therapy/non-surgical treatment was a result of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report atrial perforation, respiratory distress and medical intervention it was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade 4. It was noted torrential tricuspid regurgitation (tr). A steerable guide catheter (sgc) was advanced to the mitral valve, and the clip was successfully deployed, reducing mr. However, when the sgc was retrieved to the left atrium, a right to left shunt occurred due to the torrential tr and the patient's oxygen saturation began to drop. Therefore, an atrial septal defect (asd) occluder was implanted for additional treatment. The patient is stable. One clip was implanted, reducing mr to1. 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 Key10920714
MDR Text Key218722912
Report Number2024168-2020-09993
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 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/20/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00718U353
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 Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2020
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: 11/30/2020 Patient Sequence Number: 1
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