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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 SGC0301
Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problems Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Test Result (2695)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history did not indicate a lot-specific product issue. It should be noted that per the mitraclip instructions for use (ifu) warns the user to use proper de-airing techniques before and during use to minimize the risk of air embolism. Additionally, the ifu instructs the user to close the guide stopcock. The investigation determined the reported leak to be related to the user error. The user error was due to the user turning the stopcock in the wrong direction. The reported patient effects of oxygen level decreasing (test result) and hypotension appear to be related to patient conditions. However, since the patient pre-existing condition worsened after the leak, the procedural conditions cannot be ruled out. The reported patient effect of hypotension, as listed in the mitraclip system ifu, is a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling. (b)(4).
 
Event Description
This is being filed to report air leak, hypotension, medical intervention, and prolonged hospitalization. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3+. The patient presented with mild aortic insufficiencies. A steerable guide catheter (sgc) was advanced to the mitral valve; however, during the dilator removal, the stopcock was inadvertently turned the wrong way. A small amount of air entered the guide, but air did not enter the patient. The sgc was de-aired with standard aspirations, and then the clip delivery system was advanced into the sgc and prior to the clip exiting the tip of the guide, the patient¿s oxygen level decreased, blood pressure dropped, and the patient had severe aortic insufficiencies. The sgc was removed with the cds and the procedure was aborted. The patient was given epinephrine and an impalla left ventricular assist device was implanted for additional treatment. The patient is stable. No clips were implanted, and mr is 3+. The patient was sent to intensive care unit for additional testing. 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 Key9157724
MDR Text Key161781046
Report Number2024168-2019-12367
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648216824
UDI-Public08717648216824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/15/2020
Device Catalogue NumberSGC0301
Device Lot Number90716U108
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 Received09/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2019
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: 10/04/2019 Patient Sequence Number: 1
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