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 Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.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 reported hypotension (blood pressure drop) resulting in cardiac arrest and tachycardia (ventricular) cannot be determined.Tachycardia, hypotension and cardiac arrest are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical interventions were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.Transseptal puncture was performed, and a super stiff wire was placed in the left upper pulmonary vein.The steerable guide catheter (sgc) was advanced into the left atrium.The anesthesiology noted a drop in blood pressure.The dilator and super stiff wire were operated and retracted per instruction for use (ifu).The echnosongrapher excluded a pericardial effusion.The patient's condition worsened to cardiac arrest.Cardiopulmonary resuscitation (cpr) had to be preformed.For a few minutes the patient was stable, but then ventricular tachycardia (vt) was observed and cpr had to be performed.Cardioversion was performed and a coronary angiography, without findings.The patient was stabilized.There was no obvious reason for the cardiac arrest.The physician decided to stop the procedure and retracted the sgc out of patient.A thrombogenic event was suspected, but no thrombus was observed.The patient is stable.

• 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: 18912849
• MDR Text Key: 337764994
• Report Number: 2135147-2024-01132
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 31106R2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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