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 Problem Embolism (1829)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report embolism. It was reported that on (b)(6) 2017, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4. Two clips were successfully implanted, reducing mr to a grade of 1-2. Over two years later, the patient returned to the hospital and echocardiography showed that mr had increased to a grade of 4. The two implanted clips were noted to be stable on the leaflets and the physician stated that the recurrent mr is due to progression of disease. On (b)(6) 2020, a second mitraclip procedure was performed to treat mr with a grade of 4. The clip delivery system (cds) was inserted and advanced into the left atrium (la); however, at this time, the physician observed a flickering object around the tip of the steerable guide catheter (sgc). The physician stated that it did not observe to be thrombus. Also, during the procedure, the patient was fully heparinized and the activated clotting time (act) remained well about 250. Roughly one minute after the foreign object was noticed, it was no longer visible. It was noted that it likely dislodged and migrated to an unknown location. The procedure was continued, and the clip was successfully implanted, reducing mr to a grade of 3. It was noted that after the procedure, the patient was stable and cleared of any neurological complications. 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: 10515073
• MDR Text Key: 206342023
• Report Number: 2024168-2020-07539
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/17/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00317U323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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: 09/10/2020 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP (X2)