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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
Model Number SGC0301
Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
The device was received and investigated. The reported tear and leak was not confirmed as no leak or tear was observed. A review of the lot history record revealed no manufacturing issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and a definitive cause for the reported leak and tear cloud not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report the steerable guide catheter (sgc) leak. It was reported this was a mitraclip procedure to treat mixed mitral regurgitation. When inserting the steerable guide catheter (sgc), after the dilator and guidewire were pulled back air entered the sgc, requiring additional aspiration. A tear was noted in the sgc hemostatic valve. Air did not enter the patient. The device was replaced with a new sgc. There were no adverse patient effects and no clinically significant delay in the procedure. A new sgc was used to continue 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 Key9782214
MDR Text Key183095628
Report Number2024168-2020-01969
Device Sequence Number1
Product Code DRA
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 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number91115U218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2019
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: 03/03/2020 Patient Sequence Number: 1
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