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 08/26/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a perforation. It was reported this was a procedure to treat functional mitral regurgitation (mr) with a grade of 3. It was noted the mean pressure gradient was 1mmhg. Two clips were successfully implanted, reducing mr to a grade of 1. The gradient increased to 4mmhg. A third clip was attempted to be implanted, but the gradient increased to 6mmhg; therefore, the clip was removed. However, after the steerable guide catheter was retracted into the right atrium (ra), it was observed the sgc had caused a perforation on the fossa ovalis. No treatment was performed. After the devices were removed, the gradient returned to 4mmhg. There was no clinically significant delay in the procedure. 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: 12498881
• MDR Text Key: 272256522
• Report Number: 2024168-2021-08284
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/20/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10421R244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: 09/20/2021 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP (X2)