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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 01/03/2020
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a conclusive cause for the thrombosis could not be determined.The reported patient effect of thrombosis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was inserted into the anatomy; however, during insertion, thrombus was noted in the catheter.The sgc was removed and replaced.The thrombus was also removed with the sgc.It was noted that act remained greater than 250 seconds throughout.Additional heparin was also given.One mitraclip was successfully implanted, reducing mr to a grade of <1.There was no clinically significant delay in the procedure.No additional information was provided.
 
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Brand Name
STEERABLE GUIDE CATHETER
Type of Device
VALVE 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 Key9596404
MDR Text Key175223124
Report Number2024168-2020-00728
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 Physician
Type of Report Initial
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/06/2020
Device Catalogue NumberSGC0301
Device Lot Number90906U201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2020
Initial Date FDA Received01/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight86
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