MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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

Patient Problems Stroke/CVA (1770); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: tacticath ablation catheter, tacticath ablation catheter, se, flexibility ablation catheter.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 9680001-2020-00028, 3005334138-2020-00178, 3005334138-2020-00179.The following was published in the heart rhythm, vol 17, no 5pa, may 2020 in an article titled ¿arrhythmia recurrence is more common in females undergoing multiple catheter ablation procedures for persistent atrial fibrillation: time to close the gender gap".The purpose of this study was to determine whether multiple ablation procedures improves arrhythmia outcomes in females with psaf compared to men.A total of 281 patients underwent ablation procedures for psaf.Complications included 1 stroke and 1 phrenic nerve injury.The middle cerebral artery embolic stroke occurred at day 8 after the second procedure.The phrenic nerve injury occurred after the second procedure.

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 remains unknown.

• Brand Name: THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10029870
• MDR Text Key: 190036396
• Report Number: 2030404-2020-00030
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other