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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 04/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: (b)(4).The device was returned for evaluation.The returned device analysis found tears on the steerable guide catheter soft tip.The investigation concluded that the reported user experience and observed soft tip tear was related to procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under a separate medwatch mfr number.
 
Event Description
This report is filed for the 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 that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the left atrium.While steering down to the mitral valve, it was observed that the cds shaft was bent, and the device was diving medial and anterior.The cds was retracted back into the sgc.Resistance was noted between the clip and the tip of the sgc tip; therefore, the devices were removed together as a unit.The procedure was competed successfully using a new sgc and cds.One clip was implanted, reducing the mr to 1+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis found that the sgc soft tip was torn.
 
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Brand Name
MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of Device
STEERABLE 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 Key5736647
MDR Text Key47792347
Report Number2024168-2016-04024
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2016
Device Catalogue NumberSGC01ST
Device Lot Number50930U144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/26/2016
Initial Date FDA Received06/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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