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 Problem Air Embolism (1697)

Event Date 03/23/2023

Event Type  Injury  

Event Description

This will be filed to report an air embolism.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 3.After steerable guide catheter (sgc) insertion, air bubbles were noticed on echo imaging.Aspiration was performed but was unsuccessful due to the tip of the sgc not being able to reach the air bubbles.The physician continued the procedure without further complication and one clip implanted.It was noted that the air bubbles diminished over the duration of the procedure.The procedure was concluded with a resulting mr of grade 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.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 air embolism cannot be determined; however, embolism (air) is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 16752416
• MDR Text Key: 313435040
• Report Number: 2135147-2023-01677
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 21109R1033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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