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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 03/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The two clip delivery systems referenced are filed under separate medwatch reports.
 
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 an mr grade of 3. One clip was implanted. The second cds (60903u149), was inserted into the steerable guide catheter (sgc) and advanced to the mitral valve. During translation of delivery catheter handle, the cds would move from medial to lateral. Grasping was attempted, but difficult due to the irregular movement. The cds was removed with the clip, and replaced. The next cds ((b)(4)) was advanced; however, grasping was difficult. During repositioning, the grippers did not come back down. A gripper line break was suspected as there was no tension in the gripper lever. The clip was attempted to be inverted, but caught on the anterior leaflet and could not be freed. The posterior leaflet was able to be grasped. Deployment was started, but during removal of the gripper line, the clip tore off of the anterior leaflet, and remained attached to the posterior leaflet (slda). The mr returned to 3. The patient was converted to mitral valve replacement surgery. The devices were removed during surgery and the patient was stable post procedure. On (b)(6) 2017: the patient returned to the hospital due to pre-existing respiratory problems. The patient continues to be in stable condition. Returned device analysis on (b)(4) 2017 found that the sgc found that the tip of the device was torn. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the steerable guide catheter (sgc) was returned and the returned device analysis observed a torn sgc soft tip. 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 a definitive cause for the identified tears in the soft tip in this incident could not be determined. The returned device analysis observed tears in the soft tip which is indicative of an interaction between the clip and guide tip during retraction; however, the analysis was unable to replicate the difficulty retracting the clip as the sgc was returned bent. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, 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 Key6513351
MDR Text Key73665962
Report Number2024168-2017-03493
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeBE
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 05/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberSGC01ST
Device Lot Number60715U140
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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