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

Catalog Number SGC0702

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 10/19/2021

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 filed to report the steerable guide catheter leak. It was reported the mitraclip procedure was performed to treat grade 3 degenerative mitral regurgitation (mr). When the steerable guide catheter (sgc) was inserted into the left atrium, air bubbles were observed in the aorta. The air bubbles were successfully aspirated. Shortly after air bubbles were also discovered in the left atrial appendage which were also aspirated. Again, shortly after, air bubbles appeared in the left atrium, requiring aspiration. The decision was made to remove and replace the sgc. An air leak and broken valve is suspected; however, no visible damage was observed. No more air entered the patient with the new sgc. The procedure was finished successfully. One clip was implanted, reducing mr to 1. No additional information was provided.

• 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: 12756214
• MDR Text Key: 283832936
• Report Number: 2024168-2021-10009
• 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

• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SGC0702
• Device Lot Number: 10629R422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/07/2021 Patient Sequence Number: 1