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

Catalog Number SGC0702

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

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report during the procedure, air embolism and cardiac arrest after advancing the steerable guide catheter.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 3.After advancing the steerable guide catheter (sgc) to the left atrium, air was visible in the left atrium.The patient experienced a short cardiac arrest and medication was administered.After stabilization of the patient, the coronary vessels were checked.There was no air embolism visible; however, the sgc was exchanged.The procedure was finished successfully.One clip was implanted successfully without any further issues, reducing mr to 1-2.The patient is doing fine.No additional information was provided.

Manufacturer Narrative

The complaint device was returned for evaluation.Although there was no device malfunction/issue reported against the device, however, as the device was returned, it was visually inspected as a conservative measure and no device damage/issues were identified.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 air embolism resulting in cardiac arrest cannot be determined.The medication required was a result of case-specific circumstances.The reported patient effect of air embolism and cardiac arrest, as listed in the electronic mitraclip g4 system instructions for use (ifu), are known possible complications associated with mitraclip procedures.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: 12008993
• MDR Text Key: 256484619
• Report Number: 2024168-2021-05032
• Device Sequence Number: 1
• Product Code: DRA
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10222U101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention