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

Model Number SGC0701

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem Perforation (2001)

Event Date 05/27/2021

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 perforation, unable to straighten the device and a cable break. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter was inserted, but it was observed that when applying minus knob, the guide was unable to straighten. The physician suspected a cable break occurred; therefore, the clip was removed and replaced. It was noted that after the sgc was removed an atrial septal defect was observed. The physician decided no treatment was needed; therefore, a new sgc was inserted and one clip was successfully implanted, reducing mr to a grade of <1. 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: 12009407
• MDR Text Key: 256504338
• Report Number: 2024168-2021-05037
• 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: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/28/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10129U126
• 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: 01/29/2021
• 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: 06/16/2021 Patient Sequence Number: 1