• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problems Positioning Failure (1158); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Unintended Movement (3026)
Patient Problem Perforation (2001)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report atrial perforation difficult to remove. It was reported this was a mitaclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. It was noted there was a very tortuous venous access. The steerable guide catheter (sgc) was inserted and advanced into the left atrium (la). It was noted that due to the tortuous venous access, the sgc was difficult to advance and became kinked. Therefore, the sgc was removed and replaced. The new sgc was inserted and advanced into the la. It was noted that transseptal access was difficult. An xtw clip was inserted into the la, but at this time it was observed when rotating the guide handle, the tip of the guide did not move. It was noted that a generation 3 sgc was used with a generation 4 clip delivery system (cds). Due to the inability to steer the sgc, the physician decided to pull the clip back into the sgc and remove the devices. However, the sgc was unintentionally retracted into the right atrium (ra) and the clip remained in the la. This caused difficulty retracting the cds into the sgc. By using force, the physician was able to pull the clip through the transeptal puncture. Once in the ra, the clip was able to be retracted into the sgc and both devices were removed. Once removed, it was observed a left to right shunt was present. No additional devices were inserted, and the procedure was discontinued. Mr remained at a grade of 4. There was no clinically significant delay in the procedure. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12189222
MDR Text Key262217290
Report Number2024168-2021-06174
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeDA
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,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2021
Device Catalogue NumberSGC0302
Device Lot Number00726U148
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 Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2020
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: 07/19/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
-
-