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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 SGC0101
Device Problems Difficult To Position (1467); Physical Resistance (2578)
Patient Problem Atrial Perforation (2511)
Event Date 09/28/2016
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 steerable guiding catheter was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report that after the steerable guiding catheter (sgc) was removed, the atrial septal defect (asd) was very large and was treated with an asd occluder, which is considered medical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. The patient had a very thin/floppy septum; therefore, an occluder was planned to be placed on the septum post procedure. The steerable guiding catheter (sgc) was advanced and it was noted that it was difficult to get into position due the floppy septum, but ultimately successful. Two clips were implanted, reducing the mr to 1. After the steerable guiding catheter (sgc) was removed, the atrial septal defect (asd) was very large. It was noted that the thin septum, tricuspid regurgitation and the sgc contributed to the enlarged asd. A larger than planned asd occluder was implanted for treatment and the patient was confirmed to be stable post procedure. There was no clinically significant delay in the procedure. No additional information was provided.
 
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. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The reported patient effect of atrial septal defect (asd), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. All available information was investigated and the reported physical resistance while advancing the steerable guide catheter (sgc) appears to be a result of patient morphology/pathology. The reported patient effect of an asd was likely a result of patient and procedural conditions. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key6045516
MDR Text Key58000931
Report Number2024168-2016-07138
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberSGC0101
Device Lot Number60615U218
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 Received10/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
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: 10/20/2016 Patient Sequence Number: 1
Treatment
MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM (X2)
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