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

Model Number SGC0701

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

Patient Problems Hypoxia (1918); Perforation (2001)

Event Date 03/16/2022

Event Type  Injury  

Event Description

This is being filed to report an atrial percutaneous intervention and a drop in oxygen saturation. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+. Imaging was noted to be difficult due to shadowing. The clip delivery system (cds) was advanced and grasping was difficult due to patient anatomy, as there was a large coaptation gap. The clip was able to be implanted; however, after deployment, the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda). An additional clip was implanted to stabilize the sdla clip. The mr was reduced to 2+. After the steerable guide catheter (sgc) was removed, an atrial septal defect (asd) was noted. An asd closure device was used for treatment; however, the patient was difficult to stabilize and the oxygen had dropped. The patient continued to be monitored and was extubated later. No additional information was provided.

Manufacturer Narrative

It is unknown if the device is returning for analysis. A follow-up report will be submitted with all additional relevant information. The cds referenced is filed under separate medwatch report number.

• 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: 14053970
• MDR Text Key: 288883327
• Report Number: 2024168-2022-03763
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 11020R225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: 04/08/2022 Patient Sequence Number: 1

Treatment

STEERABLE GUIDE CATHETER