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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 04/08/2021

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 filed to report leak, air embolism and medical intervention.It was reported that this was a combination mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4 and tricuspid regurgitation (tr) with a grade of 5.It was noted dilated left atrium, restricted posterior, and enlarged left and right atria.The steerable guide catheter (sgc) was advanced to the mitral valve, and the clip was advancing into the sgc, across the septum into the left atrium when an st elevation was noted.An air embolism was assumed to have occurred and air bubbles were observed in the guide chamber.Patient was given medication to stabilize and aspirations were performed.No air was noted in the guide chamber.After a short period, the procedure continued.The clip was deployed, and the cds was removed.A second clip was successfully deployed in the tricuspid valve.Then a third cds was advanced to the tricuspid valve for off-label use; however, the clip could not grasp the posterior leaflet.Therefore the cds was removed with the clip attached.One clip was implanted in the mitral valve, reducing mr to 1-2 and one clip was implanted in the tricuspid valve, reducing tr to 2.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and without a device to analyze a cause for the reported leak could not be determined.The reported patient effect of air embolism is a cascading event of reported leak.Reported ekg/ecg changes was due to embolism.Additionally, the reported patient effect of air embolism is listed in the mitraclip g4 system instructions for use as a known possible complication associated with mitraclip procedures.The reported medication and 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.

• 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: 11725117
• MDR Text Key: 247292304
• Report Number: 2024168-2021-03522
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10112U332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 44