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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 Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2018
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 other steerable guide catheter and the clip delivery system are filed under separate medwatch report numbers.
 
Event Description
This is filed to report the torn steerable guide catheter (sgc 80111u127) soft tip. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc 80111u124) was advanced into the femoral vein, but resistance was noted. The +/- knob was turned three fourths of a turn to straighten the guide, but the sgc could not be advanced and was removed. It was observed that the sgc tip was not responding in minus direction and a cable break was suspected. A new sgc (80111u127) was advanced successfully. The first clip was implanted, reducing mr to 2. The second clip delivery system (cds 80108u208) was advanced. Visualization and grasping were difficult due to the anatomy. The cds. Was retracted, but became entangled in the chordae. Troubleshooting was performed and the clip was freed. The cds continued to be retracted, but met resistance with the sgc. The cds was pulled hard and a pop was heard. The clip detached from the cds and remained attached to the gripper and lock lines. The clip was caught on the tip of the sgc; therefore, the entire system was retracted together. The clip then caught on the septum. The clip was freed, but the atrial septal defect (asd) was enlarged due to the clip interaction. During removal of the system, resistance was felt with the femoral vein. After removal, it was observed that the sgc soft tip was torn. An asd occluder was used to treat the asd. One clip was implanted, reducing the mr to 2. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was returned for evaluation and the reported steerable guide catheter (sgc) torn soft tip was confirmed. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The reported tear in the soft tip appears to be related to user technique/procedural conditions as a result of the clip getting caught on the guide 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.
 
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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 Key7458409
MDR Text Key106742714
Report Number2024168-2018-03043
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,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/11/2019
Device Catalogue NumberSGC0301
Device Lot Number80111U127
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
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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