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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other device mentioned will be filed under a separate medwatch report.
 
Event Description
This is being filed to report the torn tip. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was successfully implanted. A second clip delivery system (cds) was advanced to the mitral valve however the mr was unable to be reduced further. The leaflets were ungrasped and the clip repositioned several times however the mr was unable to be reduced. The cds was retracted per the instructions for use (ifu) however the clip became caught on the tip of the steerable guide catheter (sgc). Standard troubleshooting was performed; however the clip could still not be retracted. The system was pulled back to the right side and pulled through the septum without issue. It was noted the clip looked like it had detached from the mandrel even though no deployment had been initiated. The sgc and cds were retracted to the groin where it was noted one clip arm was inside the sgc and one clip arm was stuck on the vessel wall. A vascular surgeon was called to perform a cut down. Once removed, it was confirmed the clip was no longer attached to the mandrel but was still attached to the cds by the lock and gripper lines. The procedure was completed at this time with the mr reduced to 3. There was no clinically significant delay in the procedure and no adverse patient sequela. Return analysis noted the tip of the sgc was torn. No additional information was provided.
 
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Brand NameSTEERABLE 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 Key9921295
MDR Text Key186367400
Report Number2024168-2020-03337
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
Type of Report Initial,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/21/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number91122U130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2019
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: 04/03/2020 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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