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

Catalog Number SGC0702

Device Problem Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leak.The air embolism appears to be related to the leak.Air embolism is listed in the instructions for use as known a possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstances as no treatment was provided for the air embolism.There is no indication of a product issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in report is filed under separate medwatch report number.

Event Description

This is filed to report leak, causing an air embolism.It was reported that mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced into the anatomy.The clip delivery system (cds) was advanced into straddling position.An air bubble was noted in the left atrium.The bubble disappeared over time and was then visible in a cusp of the aortic valve.Over time, the bubble was not visible anymore.There was no chance of aspirating the air.There was not enough air, and it was hard to reach in the cusp.It was unclear where the air originated from, but it was thought to originate after flushing the sgc after dilator removal.The procedure was continued with one clip implanted, reducing mr to grade 1.There was no clinically significant delay in the procedure and no adverse patient sequelae.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: 16628676
• MDR Text Key: 312138745
• Report Number: 2135147-2023-01374
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20817R1084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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
• Treatment: 1 MITRACLIP.
• Patient Outcome(s): Other