MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the thrombus requiring medical intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.During transseptal puncture, heparin was given but it was noted that the heparin was administered through a line that was not in the patient anatomy.The heparin line was connected properly, and the procedure continued.The steerable guide catheter (sgc) was advanced to the right atrium, and thrombus was noticed on the guide wire in the right atrium about the size of a nickel.The sgc was removed and a 6fr guiding catheter was advanced in an attempt to remove the thrombus.The guide wire was removed and the physician thought the clot had dislodged and re-crossed the guide wire to the septum through the same access site, all looked good.However, when the sgc was re-inserted, a larger thrombus was noted attached to the guide wire.Therefore, the physician decided to abort the procedure due to the patient coagulation issue.There were no clips implanted, mr remained at 4+.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that per the mitraclip g4 system instructions for use (ifu), "warning: heparinized saline flush should be continuous throughout the procedure.Discontinuing flush may result in air embolism and/or thrombus formation.Ensure flow is visible through the drip chamber and that tubing is free from kinks and/or obstruction.Ensure pressure of 300 mmhg is maintained.¿ it was reported that during transseptal puncture, heparin was given but it was noted that the heparin was administered through a line that was not in the patient anatomy which was a deviation from the ifu.Based on the information reviewed, the reported thrombosis appears to be related to user error.The reported for failure to follow steps/instructions appears to be due to user error of deviating from the instructions for use.The reported unexpected medical intervention and required medication were result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Device code 2017 - failure to follow steps.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12320945
• MDR Text Key: 266623597
• Report Number: 2024168-2021-07153
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01024U202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 87