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

Catalog Number SGC0702

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem Pericardial Effusion (3271)

Event Date 06/14/2021

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 pericardial effusion. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted the patient had a small left atrium (la) and visibility was poor. The steerable guide catheter (sgc) was inserted, but it was noted that due to a suboptimal transseptal puncture, the sgc was not able to turn in the posterior direction and became caught in tissue between the aorta and atrium, resulting in a pericardial effusion. Resulting in a clinically significant delay in the procedure. After several maneuvers were performed, the device was removed from the tissue, but continued to worsen the effusion. To treat the effusion, pericardiocentesis was performed. The physician then decided to undergo mitral valve replacement surgery. 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: 12127726
• MDR Text Key: 260238341
• Report Number: 2024168-2021-05758
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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

Device Operator

• Device Expiration Date: 02/15/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10212U201
• 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: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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: 07/07/2021 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM