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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 Leak/Splash (1354); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All the available information was investigated. The definitive cause for the reported leak could not be determined. The product quality problem appears to be related due to user technique/procedural circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional device referenced is being filed under separate medwatch report.
 
Event Description
This is being filed to report leak and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. A steerable guide catheter (sgc) was advanced to the mitral valve. Then the clip delivery system (cds) was inserted into the sgc; however, during advancement of the cds, air entered the sgc. The sgc was immediately removed from the stabilizer, positioned lower to ensure no air was inside, and additional aspirations were performed. It was confirmed there was no air in the sgc and air did not enter the patient. At that time, the cds was to be removed from the sgc; however, the clip became stuck in the clip introducer. It was suspected that the hemostasis valve of the sgc was damaged, but this could not be confirmed. Both the sgc and cds were removed from the patient. The procedure continued with a new cds and sgc. One clip was implanted, reducing mr to 1. There were no adverse patient effects and no clinically significant delay in the procedure. 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 Key9203013
MDR Text Key162841821
Report Number2024168-2019-12692
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/27/2020
Device Catalogue NumberSGC0302
Device Lot Number90627U125
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 Received09/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2019
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: 10/17/2019 Patient Sequence Number: 1
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