• 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
Model Number SGC0701
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Air Embolism (1697)
Event Date 10/21/2021
Event Type  Injury  
Event Description
This is being filed to report the air embolism requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced to the left atrium (la) when the guide wire and dilator were removed. The stopcock was accidentally partially opened during the maneuver and air entered the sgc. The sgc was immediately removed from the stabilizer and lowered below the patients heart and aspiration performed. The sgc and dilator were then removed from the patient. Both were thoroughly flushed with heparinized saline and prepared anew. Once properly de-aired, the procedure was proceeded without further issue. One clip was implanted, reducing mr to 1. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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 reported from this lot. It should be noted that the user is instructed to close the stopcock in section 21. 1 steerable guide catheter preparation of the electronic mitraclip g4 instructions for use (ifu), and the stopcock is not opened during the procedure after that. The reported air embolism was a result of the user error. Embolism/emboli is listed in the mitraclip ifu as a known possible complication associated with mitraclip procedures. The unexpected medical intervention was a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling.
 
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 Key12771818
MDR Text Key280471415
Report Number2024168-2021-10107
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCA
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 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10401R132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
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: 11/08/2021 Patient Sequence Number: 1
-
-