• 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 G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

  • 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 G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Catalog Number SGC0702
Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Event Description
This is filed to report unintended movement. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 2. It was noted restricted posterior, large left atrium appendix, and short septal lateral diameter. Imaging of the clip was difficult due to the complex anatomy. The steerable guide catheter (sgc) crossed the septum pointing towards anterior and the guide and dilator were then guided towards posterior by the wire which was placed in the left upper pulmonary vein. Therefore the tip of the dilator was a bit deflected. The sgc was advanced to the mitral valve; however, after rotating the handle clockwise, the guide tip could not curve more posterior. The cds was the advancing and the clip exited the guide, but the clip was touching the lateral wall. Therefore, the guide tip was retracted close to the septum the clip was not visible when the cds was advanced into straddling position. When trying to steer down with maximum guide retraction and a bit under straddled. M knob was removed, and an attempt was made to under straddle more, but failed. The + knob of the sgc was applied; however the tip slipped slightly to the right atrium. The cds could not be positioned. The procedure was to be aborted, but the clip was not able to be retracted. Each time the cds was retracted, the lateral wall was coming closer to the septum. The blood pressure dropped very low, and a pericardial effusion was observed severely impacting the hearts dialostic capacities. The pe was treated with pericardiocentesis. The blood pressure improved, but additional blood transfusion was needed. The cds was able to be removed into the guide, and both the sgc and cds were removed from the patient. There was visible damage to the lateral left atrium wall. The procedure was aborted and the patient remained hospitalized and was transferred to heart surgery. Mitral valve and tricuspid valve repair was successfully performed. No clips were implanted, and mr is 2. There was no clinically significant delay in the procedure. No additional information was provided.
 
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 similar complaints from the lot. All available information was investigated and the reported unintended movement of the steerable guide catheter (sgc) appears to be related to user technique/procedural circumstances. The reported difficult positioning appears to be related to patient conditions. There is no indication of a product issue with respect to manufacture, design or labeling. The additional clip delivery system referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameG4 STEERABLE GUIDING CATHETER
Type of DeviceCATHETER, STEERABLE
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 Key12778810
MDR Text Key285331739
Report Number2024168-2021-10146
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10630R449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2021
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: 11/09/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
-
-