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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER CATHETER, STEERABLE Back to Search Results
Catalog Number SGC0701
Device Problems Difficult to Flush (1251); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device was received, but the investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system that was used on this patient is being filed under a separate medwatch report.
 
Event Description
This is filed to report the air in the device. It was reported that this was a mitraclip procedure in the patient with grade 4 degenerative mitral regurgitation (mr). The steerable guide catheter (sgc) was advanced into the patient. When the physician inserted the sgc and tried to aspirate per the standard instructions, it took much longer than expected to aspirate. The tip of the sgc was confirmed on imaging to be free of any structures. Air was entering the sgc as seen by air in the fluid column but no air was introduced into the patient. It did not take more force to aspirate from the sgc, but it did take longer than usual. The same sgc was used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMITRACLIP G4 STEERABLE GUIDE 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 Key9405116
MDR Text Key177761962
Report Number2024168-2019-14069
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2020
Device Catalogue NumberSGC0701
Device Lot Number91001U209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
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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