MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE BI-DIRECTIONAL ABLATION CATHETER; IRRIGATED ABLATION CATHETER

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event of entanglement could not be confirmed.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 no lot number was provided.Based on the information received, the cause of the reported entanglement may have been procedure related.

Event Description

During the procedure, the automark lesions displayed in the inferior vena cava while the ablation location was actually in the right atrium.A pacemaker was also inserted into the patient after geometry creation.When using the ablation catheter, the device became entangled around the pacemaker.The catheter was bent following removal and was replaced.The procedure was completed with a second catheter and by manually marking the lesions with no adverse consequences to the patient.

• Brand Name: SAFIRE BI-DIRECTIONAL ABLATION CATHETER
• Type of Device: IRRIGATED ABLATION 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: 10132799
• MDR Text Key: 194477601
• Report Number: 2182269-2020-00056
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/15/2020
• Initial Date FDA Received: 06/09/2020
• 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