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
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer ref: 2182269-2021-00090.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.
Additional 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
• Common Device Name: 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: 12782812
• Report Number: 2182269-2021-00089
• Device Sequence Number: 14958784
• Product Code: LPB
• UDI-Device Identifier: 05414734205979
• UDI-Public: 05414734205979
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SAFIRE BI-DIRECTIONAL ABLATION CATHETER
• Patient Sex: Unknown