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 Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 01/19/2022

Event Type  Injury  

Event Description

This will be filed to report during use of the steerable guide catheter (sgc), a pericardial effusion occurred requiring pericardiocentesis. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation. When the physician was advancing the sgc (with dilator) across the septum, the sgc was only visualized tenting at the septum. The sgc or dilator could not be visualized in the left atrium so the physician kept advancing the sgc. The imager continued trying to visualize the sgc at the septum and the left atrium, but when visualization was captured of the sgc in the left atrium, it was almost to the left atrial wall. The clip delivery system was advanced and when grasping was performed without issue, the patient's blood pressure dropped, and a pericardial effusion was noted. Medication was given by the anesthesiologist. The clip was able to be implanted, reducing mr to 2. Then, pericardiocentesis was performed. The physician suspects that the sgc (with dilator inside) was advanced too far into the la, likely contacted & injured the atrial wall. The next day, the patient experienced some chest pain and had some ekg changes. A heart catheterization procedure was performed to see if the patient had any acute coronary artery blockages. They did not find any acute issue that warranted further intervention. The clip remained stable and there was no tissue damage noted. It is unknown if these were a result of the effusion. The patient had computerized tomography (ct) which showed no pulmonary embolism. On (b)(6) 2022, the patient was noted to be stable. 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. The clip delivery system referenced is filed under a 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: 13472499
• MDR Text Key: 285182548
• Report Number: 2024168-2022-01229
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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: 10621R159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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: 02/07/2022 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM