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

Model Number SGC0701

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/07/2021

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 thrombosis and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade 4. After transseptal access was achieved, the steerable guide catheter (sgc) and dilator were advanced across the septum with difficulty. However, an object was observed on the sgc tip. Initially it was unknown if the object was a clot or tissue. The dilator was pulled back, and aspirations were performed to pull the object into the sgc, and then poured into a bowl. The object was believed to be a clot. Medication was administered to the patient. The procedure continued with the same sgc. One clip was implanted, reducing mr to 1. There were no adverse patient effects and no reported 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: 11724390
• MDR Text Key: 247265625
• Report Number: 2024168-2021-03501
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/15/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10116U112
• 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: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2021
• 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: 04/26/2021 Patient Sequence Number: 1