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

Model Number N/A

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

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) worsening the pericardial effusion and cardiac tamponade requiring medical and surgical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.While performing the transseptal puncture, the non-abbott transseptal needle punctured the right ventricle and the patient had a pericardial effusion.No treatment was warranted, and the procedure continued.Two mitraclips were successfully implanted in the patient reducing the final mr grade to <1.Approximately 15 minutes after the steerable guide catheter (sgc) was removed, it was confirmed on transthoracic echocardiogram (tte) that the pericardial effusion had worsened.Cardiac tamponade was diagnosed and a pericardiocentesis was performed.The issue persisted and the patient was converted to open heart surgery for pericardial drainage.The wound on the right atrium had a hematoma and there was bleeding from the right ventricle.The surgery was successful, and the procedure was complete.However, there was a reported clinically significant delay in the procedure.No additional information was provided.

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 the reported event.Based on the information reviewed, the patient effect of the reported pericardial effusion appears was due to the procedural circumstance.The cardiac tamponade was a result of pericardial effusion.The reported hospitalization, unexpected medical intervention, surgical intervention, and delay to treatment were a result of case-specific circumstances.Pericardial effusion and cardiac tamponade are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 14338081
• MDR Text Key: 291223785
• Report Number: 2024168-2022-05022
• 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,Followup
• Report Date: 07/01/2022

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 Expiration Date: 11/14/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0705
• Device Lot Number: 11115R113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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
• Patient Age: 85 YR
• Patient Sex: Female