MAUDE Adverse Event Report: ST. JUDE MEDICAL FIRMAP¿ CATHETER; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): swartz braided introducer.The results of the investigation are inconclusive since the device was not returned for analysis. additionally, the device history record (dhr) was unable to be reviewed as a lot number was not provided. based on the information received, the cause of the reported incidents could not be conclusively determined.

Event Description

Related manufacturing ref: 3005334138-2020-00004.The following was published in the journal of cardiovascular electrophysiology titled, "single-center experience of the firm technique to ablate paroxysmal and persistent atrial fibrillation" by henley, patrick, et al.: four major complications occurred over the course of the study.There were three transient ischemic attacks and one cerebrovascular accident.No neurological sequelae were noted on follow-up after these events.Interestingly, all four of these patients were prescribed rivaroxaban before the procedure.All of these patients took their last dose of rivaroxaban the day before the procedure.These patients were switched to another new oral anticoagulant medication or warfarin on discharge or follow-up.Three groin hematomas, one fever and two urinary-tract infections and one incidence of epididymitis were also noted as minor complications in the acute post procedural setting.

• Brand Name: FIRMAP¿ CATHETER
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9572091
• MDR Text Key: 176849719
• Report Number: 3005334138-2020-00008
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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