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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 SGC0303
Device Problems Leak/Splash (1354); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2017
Event Type  Injury  
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 similar incidents reported from this lot. All available information was investigated and the reported soft tip tear and leak appear to be related to user technique/procedural conditions. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
 
Manufacturer Narrative
The patient and device codes were coded by the manufacturer. (b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant products: clip delivery system guide catheter: mpa 12-24 ensnare. The customer reported the steerable guide catheter was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report the steerable guide catheter (sgc) soft tip tear and loss of fluid column. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. The first clip delivery system (cds) was advanced to the mitral valve and the deployment sequence was performed. One minute after deployment, during gripper line removal, while both ends of the gripper line were still outside the handle, the clip detached from both leaflets. The clip was carefully brought back to the steerable guide catheter (sgc), but only one clip arm could be retracted in the sgc. The cds was removed and the gripper line was secured. A guide wire and snare device were used in an attempt to retract the clip into the sgc, but sgc fluid column loss was noted and the clip could not be snared. Aspiration was performed and the sgc and gripper line with the clip were removed together. After removal, it was found that the sgc tip was torn due to the interaction with the clip arms. Both devices were replaced and the procedure was completed successfully with implantation of two clips, reducing mr to 1-2+. In the physicians opinion, the clip detached due to the leaflet anatomy. There was a delay in the procedure, but no adverse patient effects were reported. No additional information was provided.
 
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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
MDR Report Key7191441
MDR Text Key287040350
Report Number2024168-2018-00384
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/11/2018
Device Catalogue NumberSGC0303
Device Lot Number70710U121
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/15/2018 Patient Sequence Number: 1
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