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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 Problem Perforation (2001)
Event Date 11/04/2021
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. The reported patient effect of perforation, as listed in the mitraclip g4 system instructions for use (ifu), is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the reported perforation (atrial: percutaneous intervention) appears to be due to procedural conditions. The surgical intervention was a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design, or labeling. The clip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report the septal injury. It was reported this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr). The first clip was implanted, without issue. To further reduce mr a second clip was advanced; however, the clip got stuck in the lateral chords. When attempting to remove the mitraclip delivery system (cds), septal height was lost. The cds was eventually removed with the clip intact; however, it is possible a leaflet tear occurred due to the clip entanglement. A septal tear was observed caused by the steerable guide catheter. Mitral valve replacement was performed, and the septal tear was surgically repaired. The surgery went well, and the patient was fine after the surgery. 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 Key12849388
MDR Text Key281577832
Report Number2024168-2021-10664
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 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10726R111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2021
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: 11/19/2021 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP(X1).
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