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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 Improper or Incorrect Procedure or Method (2017); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the sgc was returned and investigated. The returned device analysis observed a torn 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. The mitraclip instructions for use states that the mitraclip nt system is intended for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. All available information was investigated and the observed torn soft tip was due to procedural conditions as the clip was not able to be closed during removal which caused the clip frictional elements to get caught on the soft tip, resulting in the identified tears in the soft tip. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device. The clip delivery system is filed under a separate medwatch report number.
 
Event Description
This is filed to report the torn tip. It was reported that this was a mitraclip procedure to treat severe tricuspid valve regurgitation (tvr). The clip delivery system (cds) was advanced to the tricuspid valve. During positioning, the clip was inverted to be retracted to the right atrium, but became caught on chordae. Standard troubleshooting was performed, and the clip was freed successfully, with no damage. An attempt was then made to close the clip, but the clip would not close and was stuck open at 60 degrees. At this point, it appeared that the clip was separated from the mandrel, and was hanging loosely at the end of the cds. The cds was removed with the gripper and lock lines left in place. A snare was used to flip the clip so its end was pointing into the steerable guiding catheter (sgc). There was some resistance noted with the tip of the sgc as the clip was in an open position. The sgc was then retracted to the groin, with the clip just at the guide tip. A partial cut down procedure was performed and the clip was successfully removed. It was suspected that the sgc tip was torn due to the interaction with the clip, but this was not confirmed. Additionally, after the clip was removed, it was suspected that the harness was missing. No further clips were attempted and the procedure was discontinued. The patient remains stable. 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
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 Key6312839
MDR Text Key67230753
Report Number2024168-2017-01052
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
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2017
Device Catalogue NumberSGC0301
Device Lot Number61011U131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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: 02/08/2017 Patient Sequence Number: 1
Treatment
MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
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