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

Catalog Number SGC0702

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

Patient Problems Non specific EKG/ECG Changes (1817); Embolism/Embolus (4438)

Event Date 01/12/2023

Event Type  Injury  

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 air embolism resulting in ekg/ecg (electrocardiogram) changes cannot be determined.However, air embolism is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

Event Description

This is filed to report air embolism.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was inserted without issues.However, while retracting the dilator from the sgc, st-elevations were noted electrocardiogram (ecg).The physician then observed air in the coronary arteries.There was no leak in the device and the air was suspected to have been in the iv line when flushing the sgc.After roughly five minutes, no treatment was performed and the patient¿s parameters were stabilized.Therefore, the procedure was continued, and one clip was successfully implanted, reducing mr to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• 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: 16272607
• MDR Text Key: 308481974
• Report Number: 2135147-2023-00334
• 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
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20803R1091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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