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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 SGC01ST
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sgc was returned and investigated and was noted to have a torn soft tip. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The returned device analysis confirmed tears in the soft tip which is indicative of an interaction between the clip and guide tip during retraction. All available information was investigated and a definitive cause for the identified tears in the soft tip could not be determined. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device. The clip delivery system was filed under mfr report # 2024168-2017-05691.
 
Event Description
This is filed to report the steerable guide catheter (sgc) soft tip tear. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. Two clips were implanted without issue, reducing the mr to moderate. The third clip delivery system (cds) was advanced for lateral placement, close to the commissure. The leaflets were successfully grasped, but the clip failed to deploy. The decision was made to remove the cds with the clip. While retracting the clip into the sgc, the clip detached from the cds, inside the sgc. There was no resistance noted within the sgc, and the clip was successfully removed with the cds. Two clips were implanted, reducing the mr to 3. The patient was confirmed to be stable post procedure. There was no clinically significant delay in the procedure. Returned device analysis found that the sgc soft tip was torn. No additional information was provided.
 
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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 Key6982113
MDR Text Key91091411
Report Number2024168-2017-08500
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberSGC01ST
Device Lot Number61003U201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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