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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 Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The clip delivery system device referenced is filed under a separate medwatch report.
 
Event Description
This is filed to report that the steerable guide catheter (sgc) soft tip was torn. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3 and at the same time to treat the tricuspid valve. Echo imaging was challenging. Two clips were successfully implanted, reducing mr to <1. To treat the tricuspid valve, the mitraclip delivery system (cds) (61129u123) was advanced to the tricuspid valve, however during positioning the clip got caught in the chordae, causing tissue damage. The clip was freed from the chordae and the decision was made to discontinue the procedure. The clip was in the closed position when retracting into the sgc, and the clip got caught in the guide tip of the sgc. After removal of the devices it was noted that the gripper line was broken, the grippers could not be raised. A tear was noted on the soft tip of the sgc. No clips were implanted in the tricuspid valve. There were no adverse patient effects and there was no clinically significant delay during the procedure. The patient is stable. No additional treatment is planned. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The reported device was not returned for analysis. 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. All available information was investigated and the reported tears in the soft tip resulting from the clip getting caught on the guide tip appears to be related to procedural conditions/user technique. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key6429284
MDR Text Key70970463
Report Number2024168-2017-02449
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/26/2017
Device Catalogue NumberSGC0302
Device Lot Number61026U201
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 Received04/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

Patient Treatment Data
Date Received: 03/23/2017 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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