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

Catalog Number SGC0702

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

Patient Problem Pericardial Effusion (3271)

Event Date 01/16/2024

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 that would have contributed to this event.The investigation was unable to determine a cause for the reported pericardial effusion.Pericardial effusion is listed in the instructions for use is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance as pericardiocentesis was performed to treat the pericardial effusion.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3 and a pre-existing 0.2 cm pericardial effusion.A transseptal needle was inserted and advanced, and several attempts for transseptal puncture were performed, the pericardial effusion measured at 0.3cm.A steerable guide catheter (sgc) and mitraclip ntw were inserted and advanced to the mitral valve without issues.The mitraclip implanted without issues.The procedure was completed with 1 clip implanted, reducing the mr to a grade of 1.However, three hours post procedure, the pericardial effusion worsened.To treat the pericardial effusion, pericardiocentesis was performed.It was noted that there were no device malfunctions and no allegations against any abbott products.There was no clinically significant delay in the procedure.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• 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: 18642056
• MDR Text Key: 334566440
• Report Number: 2135147-2024-00494
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30227R1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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