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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 SGC0301
Device Problems Difficult to Remove (1528); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The clip delivery system referenced is filed under a separate medwatch report.
 
Event Description
This is filed to report a tear in the soft tip of the steerable guide catheter (sgc). It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. Advancement of the clip delivery system (cds) was performed without issue. The patient weighed (b)(6) making the visibility of the clip more challenging. Due to the flailing and severely prolapsed posterior leaflet attempts to grasp and maintain capture of the leaflets failed. The cds was retracted, but got caught on the soft tip of the sgc. The clip was opened slightly and moved away from the tip of the guide and reclosed and retracted again without any further issue. After removal of the sgc, the soft tip was observed to be torn, but still intact. The final mr grade was 4. No further treatment was performed. No adverse patient effect or clinically significant delay in the procedure was reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). All available information was investigated and the reported torn soft tip was confirmed. The reported difficulty removing the clip delivery system/cds (clip caught on soft tip) was not confirmed. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and the reported clip getting caught on the guide tip, resulting in the tear in the soft tip appears to be related to user technique due to slight rotation of the clip while retracting the cds. 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 Key7466209
MDR Text Key106843285
Report Number2024168-2018-03111
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 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/30/2018
Device Catalogue NumberSGC0301
Device Lot Number71028U141
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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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