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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0302
Device Problem Leak/Splash (1354)
Patient Problem Thrombosis (2100)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the leak and thrombosis.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was advanced into the right atrium (ra).Thrombus was then noted on the guide wire in the ra.The patient was on heparin and the activation clotting time (act) time was less than 250 seconds.The sgc was removed and aspiration was performed.The sgc was re-prepped and advanced into the anatomy.During retraction of the dilator, air was noted in the transparent hemostatic valve housing.It is possible that this was caused by contact with the heart tissue that created a vacuum, but this could not be confirmed.The sgc was retracted and blood was aspirated with no air aspiration.The dilator was removed, and the thumb was needed to close the hemostatic valve.After removal of the thumb, air was noted in the transparent hemostatic valve housing.The thumb was placed again to prevent new air from coming into the hemostatic valve with the sgc positioned below the left atrium and to allow blood to fill the guide lumen.Aspiration was performed.The sgc was removed and replaced with a new sgc to successfully complete the procedure.One clip was implanted, reducing mr to 1.There was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Internal file number: (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 identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported air in hemostasis valve in this incident could not be determined.The reported patient effect of thrombosis could not be determined.The reported patient effect of thrombosis is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of Device
STEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key8169353
MDR Text Key130498395
Report Number2024168-2018-09746
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/28/2019
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? Yes
Device Operator Health Professional
Device Expiration Date03/15/2019
Device Catalogue NumberSGC0302
Device Lot Number80315U249
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received03/22/2019
Supplement Dates FDA Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
STIFF EXCHANGE GUIDE WIRE; STIFF EXCHANGE GUIDE WIRE
Patient Outcome(s) Required Intervention;
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