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 03/17/2022

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. The additional devices are filed under separate medwatch report numbers.

Event Description

This will be filed. It was reported there was an atrial septal defect requiring intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip (11014r315) was successfully implanted on the medial part of the valve, a second clip (11123r374) was successfully implanted medially to the first. A third clip (10823r263) was implanted in the center of the valve. After deploying the third clip a laceration was noted on the anterior leaflet at the level of the second clip, and it was observed that the second clip had detached from the anterior leaflet and remained on the posterior leaflet (single leaflet device attachment (slda)). A fourth clip (11116r282) was positioned medially to the second clip, after a few grasping attempts it was noted that the first clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda). The fourth clip was successfully implanted stabilizing the first and second clip. The mr remained at a grade of 4. Following removal of the steerable guide catheter (sgc) shunt flow was noted between the right and left atrium and an atrial septal occluder was implanted eliminating the flow. There was no clinically significant delay in the procedure and no adverse patient sequela. 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: 14073986
• MDR Text Key: 288994634
• Report Number: 2024168-2022-03846
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: SGC0702
• Device Lot Number: 11028R252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: 04/11/2022 Patient Sequence Number: 1

Treatment

IMPLANTED MITRACLIP(X3); STEERABLE GUIDE CATHETER