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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 Unspecified Tissue Injury (4559)
Event Date 10/05/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The first clip referenced is filed under a separate medwatch report number.
 
Event Description
This is being filed to report thrombus. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+. After the transseptal puncture and when the steerable guide catheter (sgc) was advanced through the septum a mass was noted to be floating right at the puncture point next to the sgc. The dilator was removed from the sgc and the mass was aspirated, while bridging medication (heparin) was administered. The mass was secured in a 50cl syringe and appeared to be connective tissue of approx. 1 cm in length. The sgc then was prepared again completely and reinserted into the left atrium with the dilator. Then, the clip delivery system (cds) was advanced to the mitral valve and when checking the grippers individually, the gripper with tactile did not come down. Troubleshooting was performed, gripper levers were retracted and advanced multiple times but was unsuccessful. The cds was then removed and a new cds was used to complete the procedure successfully. One clip was implanted, reducing mr to 1. There was no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
 
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. Based on available information, a cause for the reported tissue injury could not be determined. However, the reported patient effect of tissue injury is listed in the instruction for use (ifu) as a known possible complications associated with mitraclip procedures. The reported medical intervention was a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling.
 
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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 Key12704006
MDR Text Key278555599
Report Number2024168-2021-09648
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2022
Device Catalogue NumberSGC0702
Device Lot Number10429R304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2021
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: 10/27/2021 Patient Sequence Number: 1
Treatment
STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
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