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

Catalog Number SGC0702

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

Patient Problem Perforation (2001)

Event Date 11/19/2021

Event Type  Injury  

Event Description

This is filed to report atrial perforation, tissue damage and prolonged hospitalization. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted enlarged atrium and enlarged ventricle with unusual cardiac axis. Visualization was difficult due to anatomical challenges. The steerable guide catheter (sgc) was advanced to the mitral valve, and two clips were deployed. Then after the sgc was retracted back into the right atrium, a large tearing in the fossa ovalis was observed. Due to the patient also having tricuspid regurgitation, a biphasic shunt occurred between the left and right atrium. A closure device was not used due not having the proper sizing. The shunt was not treated and since the patient is not in a critical condition, additional treatment will be performed at a later date. The patient will remain hospitalized. Two clips were implanted, reducing mr to 2. 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.

• 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: 12983497
• MDR Text Key: 282105571
• Report Number: 2024168-2021-11474
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: SGC0702
• Device Lot Number: 10719R355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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: 12/13/2021 Patient Sequence Number: 1

Treatment

2 IMPLANTED MITRACLIPS