MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

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

Patient Problem Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing reference: 2030404-2019-00089.The following was published in acta cardiological sinica in an article titled "acute outcomes for cryoablation in pediatric patients with perinodal tachyarrhythmia: single center report" by kun-lang w, shuenn-nan c, et al.2019;35:134-143.Doi: 10.6515/acs.201903_35(2).20180903a."cryoablation is an alternative treatment for atrioventricular nodal reentrant tachycardia (avnrt) and right anteroseptal and midseptal accessory pathways (aps) with a low complication rate.A high recurrence rate is still a concern in pediatric patients.From february 2015 to march 2017, fifty-two patients underwent cryoablation for supraventricular tachycardia.The median age at the time of the procedure was 15.6 years.The median total procedure time was 114 min, and the median fluoroscopy time was 25.9 min.After a median 6 attempts of cryomapping and 3 of cryoablation, the arrhythmia substrate was successfully ablated in 51 of 52 patients.One patient had first degree av block, 10 patients developed transient second degree atrioventricular (av) block but none had permanent av block or other complications.".

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was not reviewed as the batch number was not available.Based on the information received, the cause of the reported heart block could not be conclusively determined.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8965807
• MDR Text Key: 156635052
• Report Number: 2182269-2019-00157
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K102721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: 08/15/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/10/2019
• 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
• Treatment: INQUIRY¿ FIXED CURVE DIAGNOSTIC CATHETER