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

Catalog Number SGC0705

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/24/2023

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 contributed to the reported event.Based on the information reviewed, a cause for the perforation and pericardial effusion resulting in cardiac tamponade and hypotension cannot be determined.Pericardial effusion, cardiac tamponade, perforation and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention, medication required and surgical intervention were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report hypotension, a pericardial effusion, tamponade, atrial perforation, medication and intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.When the first clip used xtw mitraclip (lot#: 30327r1094) was advanced to the left ventricle, blood pressure dropped from 80mmhg to 50mmhg.It was thought the blood pressure drop was transient mr exacerbation from the clip being in the ventricle, so the procedure continued.After the clip had grasped successfully, there was no improvement in the blood pressure.Echocardiography imaging revealed pericardial effusion around the lateral side of the heart and right atrium, suggesting cardiac tamponade.The clip was implanted successfully and then pericardiocentesis was performed.The steerable guide catheter (lot#: 30419r1061) was then removed and protamine was administered.The pericardial effusion was not showing signs of resolving, so a thoracotomy was performed.During the thoracotomy, a left atrial perforation was confirmed from the cranial direction and the posterior wall side of the left atrium, and the increase in pericardial effusion stopped with a patch.A new sgc (lot: 30419r2037) was inserted and a second xtw mitraclip (lot: 30405r1015) was implanted successfully, reducing mr to trace.No additional information was provided.

• 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: 17563743
• MDR Text Key: 321323267
• Report Number: 2135147-2023-03583
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2024
• Device Catalogue Number: SGC0705
• Device Lot Number: 30419R1061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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