MAUDE Adverse Event Report: ST. JUDE MEDICAL SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 402806

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

Related manufacturer ref: 2182269-2021-00089.During an atrioventricular nodal reentrant tachycardia ablation procedure, a prolonged procedure occurred.Initially when attempting to ablate, two seconds of radiofrequency energy was delivered and then the ampere generator stopped.The ampere screen displayed "no catheter connected".The catheter connecting cable was reconnected on both ends, but the issue remained.The connecting cable was exchanged, which resolved the issue temporarily, but then the issue reoccurred.The ampere generator was replaced, but the issue remained.The catheter was exchanged and it was possible to then deliver energy, but then a high impedance issue was noted.A non-abbott generator was switched to in addition to a non-abbott ablation catheter and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One 4mm tip, small sweep, safire ablation catheter was received for evaluation.Electrode 1 and the thermistor/thermocouple met specifications during electrical testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issues remains unknown.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12782817
• MDR Text Key: 282118527
• Report Number: 2182269-2021-00090
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05414734205979
• UDI-Public: 05414734205979
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 402806
• Device Catalogue Number: 402806
• Device Lot Number: 7693429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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: SAFIRE BI-DIRECTIONAL ABLATION CATHETER