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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 Problems Difficult to Remove (1528); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2016
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 additional relevant information. The mitraclip clip delivery system referenced is filed under a separate medwatch report.
 
Event Description
This report is filed for difficulty removing the steerable guide catheter and for a tear noted on the soft tip of the steerable guide catheter. A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4. The mitraclip delivery system (cds) was advanced to the mitral valve leaflets, however, positioning the cds was difficult due to the tilted, rotated heart. Leaflet grasping was performed with the clip placed in different positions, however; mr could not be reduced. The clip was not implanted. Attempts were made to retract the closed clip into the steerable guide catheter (sgc); however, the clip got stuck at the tip of the sgc. Resistance was felt during removal of the sgc and cds at the groin area. The clip was unlocked, opened and retracted into the sgc to aid in removal. The sgc and cds were both removed from the patient anatomy without further issue. Once outside the patient anatomy a tear was observed on the tip of the sgc, however, there was no loss of tip material. The procedure was aborted. No clips were implanted. The mr remains 3-4. There were no adverse patient effects and no clinically significant delay in the procedure. The patient is stable. No additional treatment has been planned for the patient. 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 lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and the reported difficulty removing the device and soft tip tears appear to be a result of procedural conditions and secondary effects to the clip being caught on the soft tip. 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 Key6055392
MDR Text Key58600779
Report Number2024168-2016-07284
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 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue NumberSGC01ST
Device Lot Number60526U220
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 Received11/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2016
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: 10/25/2016 Patient Sequence Number: 1
Treatment
MITRACLIP CLIP DELIVERY SYSTEM
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