• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue. Based on the available information, a cause of the reported atrial perforation could not be determined. The cause of the reported hypotension could not be determined. The reported patient effect of atrial perforation and hypotension as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures. The reported hospitalization and required medication were a result of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report after the procedure an atrial septal dissection was noted. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. There was some difficulty during transseptal puncture but was achieved. The steerable guide catheter (sgc) was advanced without issue and placed in position. Two clips implanted successfully, reducing mr to 1+. The patient was stable. However, the next day the patient blood pressure dropped, and it was noted that an atrial septum dissection had occurred. There is a possibility that it could have occurred during transseptal puncture and the sgc could have worsened it. The physician commented that this was a rare entity. There was no treatment performed for the atrial septal dissection. The patient remained hospitalized for monitoring and medication was administered for the hypotension. The clips remained stable on both leaflets and mr remained at 1+. No additional information was provided.
 
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 Key12527059
MDR Text Key273152652
Report Number2024168-2021-08555
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/13/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10514R144
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 Manufactured05/14/2021
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: 09/24/2021 Patient Sequence Number: 1
-
-