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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The investigation determined that the reported failure to advance resulting in steerable guide catheter (sgc) soft tip damage appeared to be related to patient anatomy. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report soft tip tear. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. During insertion, the steerable guide catheter (sgc) met resistance with the anatomy and did not reach the septum. The sgc was removed and tears on the soft tip were observed. It was noted that the course of the vein was altered by cancer. The physician stated that stenosis developed in the veins caused by cancer which affected the right femoral vein access. Therefore, the second sgc was advanced through the left groin. Two clips were implanted, reducing mr to 2. No additional information was provided.
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
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 Key9757570
MDR Text Key181160124
Report Number2024168-2020-01784
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
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 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/16/2020
Device Catalogue NumberSGC0302
Device Lot Number90817U145
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 Received02/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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