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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Additionally, a review of the complaint history identified no other complaints reported from this lot. All available information was investigated and the reported torn, split or cut material (soft tip tear) appears to be related to the procedural conditions. There is no indication of a product issue with respect to manufacture, design or labeling. The additional device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report torn steerable guide catheter 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) was advanced to the mitral valve, and the first clip was deployed. Then a second clip delivery system (cds 01105u150) was advanced to the mitral valve, and the clip was placed. However, during the deployment sequence, the lock line became stuck. A decision was made to deploy the clip due to part of the gripper line had been inadvertently pulled into the handle of the delivery catheter, preventing the grippers from releasing the leaflets. There was an attempt to remove the cds over the lock line, but due to tension, the clip became fully detached from the valve. As the clip was still attached to the lock line, the clip was secured to the tip of the sgc. An attempt was made to retract the clip into the sgc when the lock line broke causing the clip to embolize into the mouth of the superior vena cava (svc). The clip was snared and withdrawn into the sgc. But then the sgc tip became torn. Therefore, after the sgc was removed, the procedure continued with a new sgc. It was noted a small knot was observed on the lock line after the embolized clip was removed. The new sgc was advanced to the mitral valve, and a third cds (00827u218) was advanced to the mitral valve; however, the clip could not grasp both leaflets. Therefore, the cds was removed with the clip attached. The procedure ended at this point. One clip was implanted, reducing mr to 3-4. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11286774
MDR Text Key231654574
Report Number2024168-2021-00910
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Catalogue NumberSGC0302
Device Lot Number00928U145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2020
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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