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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 Unintended Movement (3026)
Patient Problem Perforation (2001)
Event Date 11/02/2021
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 the reported issue. A review of the compliant history identified no similar incident reported from this lot. Based on information reviewed and without the device to analyze, a cause for the reported unintended movement in this incident could not be determined. The reported perforation appears to be a result of procedural circumstances. The reported patient effect of perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures. The reported unexpected medical intervention was 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 atrial perforation and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted a pre-existing atrial septal defect (asd). The steerable guide catheter (sgc) was advancing to the mitral valve; however, wire access was lost twice and the transseptal puncture had to be re-performed two additional times. The sgc was advanced to the mitral valve, and one clip was deployed. The physician closed the septum with a transseptal plug due to the pre-existing asd that the sgc possibly worsened. One clip was implanted, reducing mr to 2. 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 Key12861778
MDR Text Key281157799
Report Number2024168-2021-10739
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 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/02/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10603R111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2021
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: 11/23/2021 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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