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

Catalog Number SGC0702

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 02/03/2022

Event Type  Injury  

Event Description

This is filed to report leak, air embolism, delay and prolonged hospitalization, and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.A steerable guide catheter (sgc) was advanced to the mitral valve; however after the dilator was retracted from the sgc, air was observed in the guide.Additionally, the echocardiographer observed air in the apex of the heart causing a clinically significant delay in the procedure.The air was then immediately aspirated from the guide and a pigtail catheter was advanced to the heart to fully remove the air from the heart.Then the procedure continued and the clip delivery system (cds) was inserted into the sgc.However, prior to the clip reaching the heart, the patient's blood pressure quickly dropped and the patient was resuscitated.The cds was immediately removed with the clip attached and the sgc was retracted from the heart into the vena cava inferior.The procedure was paused to place an impella pump and perform cardial reanimation.When the impella was positioned and taking over the pumping, a decision was made to continue with the mitraclip procedure.A new sgc was being prepared for use due to the origin of the air seemed unclear.During preparation of the new sgc, the patient's blood pressure dropped again and the patient required cardial reanimation again.The initial sgc was removed from the patient and the mitraclip procedure was aborted.The echocardiographer assumed that some air went into the coronaries as the right heart did not have any ejection fraction (ef) anymore, an extracorporeal membrane oxygenation (ecmo) was installed to keep the patient stable.The patient is currently stable, but in critical condition in the intensive care unit and will remain hospitalized.No clips were implanted, and mr is 3-4.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

All available information was investigated and the reported steerable guide catheter (sgc) leak was not confirmed via returned device analysis.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 other complaints from the lot.All available information was investigated and a cause for the reported leak in this complaint could not be determined.The reported air embolism, hypotension and cardiac arrest associated with right heart not having any ejection fraction (ef) appears to be related to the procedural conditions associated with the sgc leak.Air embolism, hypotension and cardiac arrest are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The unexpected medical interventions, delay to treatment/therapy and hospitalization 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
• Type of Device: CATHETER, 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 Key: 13569126
• MDR Text Key: 288630976
• Report Number: 2024168-2022-01756
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10909R115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention