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 10/08/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have influenced the reported events. Based on this information, the reported perforation was due to procedural conditions. The reported patient effect of cardiac perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a shunt. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. Two clips were successfully deployed on the mitral valve, reducing mr to a grade of 1. However, after removing the steerable guide catheter (sgc), a right to left shunt was observed. No treatment was performed, and the procedure was discontinued. 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: 12729025
• MDR Text Key: 279315527
• Report Number: 2024168-2021-09775
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/17/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10518R208
• 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: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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: 11/01/2021 Patient Sequence Number: 1

Treatment

IMPLANTED MITRACLIP (X2)