MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE BI-DIRECTIONAL ABLATION CATHETER 4 & 8 MM TIP UNIVERSAL TEMPERATURE MONI; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 402821

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

The reported event of an expired catheter was confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.It should be noted that the reported incident date was after the product "use by"/"use before" date.

Event Description

During the procedure, an expired catheter was used.The catheter was opened and used seven days beyond the expiration date.The catheter was opened by clinical staff, and the packaging was not checked until after the procedure had been completed.The patient experienced no adverse consequences.

• Brand Name: SAFIRE BI-DIRECTIONAL ABLATION CATHETER 4 & 8 MM TIP UNIVERSAL TEMPERATURE MONI
• Type of Device: CARDIAC ABLATION PERCUTANEOUS 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: 10987009
• MDR Text Key: 220885015
• Report Number: 2182269-2020-00114
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P960016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 402821
• Device Lot Number: 6149649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• 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