MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Based on available information, the reported damaged femoral artery appears to be due to challenging patient anatomy.The reported hemorrhage and hematoma appear to be cascading events of the damaged femoral artery.Additionally, hematoma, hemorrhage, and perforation are listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported surgery and hospitalization were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed for perforation of vessels, hospitalization, and surgical intervention.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022, to treat functional mitral regurgitation (mr) with a grade of 4.The anterior and posterior leaflets were restricted.One clip was implanted reducing the mr grade from 4 to 1.The steerable guide catheter (sgc) was straightened with the "-" knob and removed from the femoral vein.During groin management it was found that the femoral artery was damaged and this was confirmed with angiography.In the physicians opinion the damage occurred during femoral vein access due to patient anatomy.The groin was surgically closed.There was no clinically significant delay in the procedure.The patient was discharged on (b)(6) 2022.The patient was hospitalized again on (b)(6) 2022 for groin swelling due to a hematoma.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15117038
• MDR Text Key: 296749926
• Report Number: 2024168-2022-08258
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0702
• Device Lot Number: 11007R113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization