MAUDE Adverse Event Report: ABBOTT MEDICAL SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI; Cardiac ablation percutaneous catheter

Model Number	402810
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a svt left lateral accessory pathway procedure, the patient went into vt/afib requiring cardioversion and transseptal access was lost resulting in cancellation of the procedure.After inserting the safire catheter, high impedance was observed.When ablation came on, it would spike for one second and then drop to almost nothing.A new cable and grounding pad were added but no resolve.When pulling the sheath and catheter back to swap for a new safire catheter, the patient went into vt / afib and transseptal access was lost.The sheath and catheter were then pulled into the right atrium.It is alleged that once the sheath was pulled back, the catheter was sticking out of the sheath and made contact with the heart causing the vt/afib, not the impedance issues.The patient was cardioverted and stabilized.Transseptal access was then unable to be reobtained.Getting transseptal access was also difficult initially due to the size of the heart.Another cath doctor was called in originally to assist as the patient was also hemodynamically unstable.
Additional Manufacturer Narrative
One 4mm tip, medium curl, safire ablation catheter was received for evaluation.Electrode 1 and the thermistor/thermocouple met specifications during electrical and temperature testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported arrhythmia and impedance issue 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): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22910229
• Report Number: 2182269-2025-00075
• Device Sequence Number: 18424586
• Product Code: LPB
• UDI-Device Identifier: 05414734206013
• UDI-Public: (01)05414734206013(10)10688915(17)271231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: 402810
• Device Catalogue Number: 402810
• Device Lot Number: 10688915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• 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: 08/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 29 KG