MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Catalog Number SGC0702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Pericardial Effusion (3271)

Event Date 08/24/2023

Event Type  Death  

Event Description

This is filed to report pericardial effusion, cardiac tamponade, cardiogenic shock, unexpected intervention, surgical intervention, and death.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.Activated clotting time (act) level was checked regularly and adjusted to heparin.Act was maintained at >250 seconds throughout the procedure.The steerable guide catheter (sgc) was advanced to left atrium.When a xtw clip delivery system (cds) was introduced 20 centimeters into the guide the patient became hypotensive and circulatory unstable.Pericardial effusion was detected.The patient was connected to extracorporeal membrane oxygenation (ecmo).Pericardiocentesis was attempted but was unsuccessful.The effusion led to cardiac tamponade.The patient became further circulatory unstable and the heart no longer had enough ejection capacity.The patient was ventilated and the heart was manually compressed at a rate of about 100 bpm.The surgical team was brought in and open heart surgery was performed.The pericardial effusion was able to be stopped however, the patient was defibrillated several times.The patient died on the table during the surgical intervention approximately 40 minutes after the onset of the pericardial effusion.The exact cause of death is unknown.It is unknown if the sgc or cds contributed to the pericardial effusion and subsequent death.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

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.Based on the information reviewed, a cause for the reported pericardial effusion, resulting in hypotension, cardiac tamponade and cardiogenic shock associated with the patient being circulatory unstable and the heart not having enough ejection capacity, cannot be determined.Additionally, while an exact cause of death could not be determined; however, based on the information reviewed, the reported death appears to be related to procedural related complications.Pericardial effusion, hypotension, cardiac tamponade, cardiogenic shock and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical interventions and surgical intervention were 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 (CE)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17765752
• MDR Text Key: 323626955
• Report Number: 2135147-2023-04045
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30309R1109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Death; Life Threatening