MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SUPREME¿ ELECTROPHYSIOLOGY CATHETER; DIAGNOSTIC EP CATHETERS

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

Patient Problem Vasoconstriction (2126)

Event Type  Injury  

Event Description

During a procedure, a venospasm was observed requiring administration of intravenous isosorbide dinitrate.A patient with ischemic cardiomyopathy, a left ventricular (lv) ejection fraction of 23%, left bundle branch block with a qrs duration of 160 milliseconds, and non-sustained ventricular tachycardia was admitted for cardiac resynchronization therapy combined with an implantable defibrillator.During lv lead placement, the guiding sheath encountered strong resistance during deep coronary sinus (cs) cannulation.Cs venography showed a complete occlusion.Venospasm was the diagnosis because the occlusion self-resolved after several minutes.After administering intravenous isosorbide dinitrate and waiting several minutes without manipulating the catheters, the lv lead was successfully placed in the target branch.Although the cs spasm was considered a rare complication of the lv lead placement, in some cases catheter manipulation can trigger it.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: DIAGNOSTIC EP CATHETERS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16125512
• MDR Text Key: 306975139
• Report Number: 2182269-2023-00001
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002976
• 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: 02/13/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other