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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 Thrombosis (2100)
Event Date 10/26/2020
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 available information, a cause for the reported thrombosis could not be determined. The reported patient effect of thrombus is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures. The reported additional therapy/non-surgical treatments were results of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system (cds) referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report thrombus during use of the steerable guide catheter (sgc) which was treated with aspiration. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4. The clip delivery system (cds) was advanced and when steering down to the valve and positioning the clip over the jet a cluster/formation was noted on the underside of the clip. Transesophageal echocardiography (tee) confirmed that it was a clot on the tip of the clip. The patient had been given heparin, but it was decided that removing the device was safest option. The clip was slowly navigated into the steerable guide catheter (sgc) to not disturb the clot. Once the clip was inside the sgc, the clot was aspirated while removing the clip. Once outside of the patient anatomy, the clot was noted on the gripper of the clip. The sgc was replaced as well as the clot could have been introduced by the sgc or left behind in the sgc. One clip was implanted, reducing mr to 1. 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 Key10830106
MDR Text Key215957425
Report Number2024168-2020-09442
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCA
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 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/26/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00826U230
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 Received10/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2020
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: 11/12/2020 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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