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 02/01/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 3-4.A transseptal needle was advanced, but while measuring the height under echocardiography, the transseptal was unable to viewed.Therefore, the transseptal needle was prepared again, and while preparing the puncture, a pericardial effusion was observed.In the physician¿s opinion, the pericardial effusion was not severe, and therefore, the procedure was continued.After the puncture, a steerable guide catheter (sgc) was inserted and the mitraclip inserted and were advanced to the mitral valve.However, echocardiography revealed that the pericardial effusion worsened.It was noted that it was likely due to the sgc as it was introduced too far into the left atria.Therefore, the sgc and mitraclip were removed from the patient and the procedure was discontinued.The pericardial effusion was treated.No clips were implanted.The mr remained at a grade of 3-4.There was no clinically significant delay in the procedure.

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.Based on available information, a cause of the reported pericardial effusion could not be determined.The reported patient effect of pericardial effusion, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18771276
• MDR Text Key: 336185702
• Report Number: 2135147-2024-00852
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0702
• Device Lot Number: 30911R2015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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