MAUDE Adverse Event Report: Abbott Medical Fast-Cath¿ Transseptal Guiding Introducer Swartz¿ SL Transseptal Series, SL1¿ 8.; Introducer, Catheter

Model Number	406849
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, st elevation was noted during a guidewire exchange in the fast-cath sheath.Following difficult femoral venous access and transseptal puncture, the physician opted to switch to a stiffer guidewire to help advancement of the agilis sheath through the kinked femoral vein.The fast-cath sheath was in the left atrium, and the guidewire was located in the left superior pulmonary vein.While withdrawing the guidewire, the patient developed st elevation on the ecg.It was noted that the guidewire was not withdrawn with the dilator, which is alleged to have caused air bubbles that presumably got into the coronaries.The patient became hemodynamically unstable, pulse was lost, asystole on ecg and decrease in blood pressure.Akrinor was administered for hemodynamic support.Cpr was performed for a few seconds.Heartbeat was obtained with only a rate of approximately 30 beats per minute.Emergent ventricular pacing was started and performed by an inquiry catheter which was placed in the rv.The st elevation was noted to gradually resolve over the next few minutes.The patient's hemodynamic condition slowly stabilized and ventricular pacing was able to be discontinued.The procedure was cancelled and the patient was transferred out of the operating room in stable condition.

• Brand Name: Fast-Cath¿ Transseptal Guiding Introducer Swartz¿ SL Transseptal Series, SL1¿ 8.
• Common Device Name: Introducer, Catheter
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50181583
• Report Number: 3005334138-2026-00399
• Device Sequence Number: 9886565
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: (01)05414734203388(10)11222526(17)281231
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 406849
• Device Catalogue Number: 406849
• Device Lot Number: 11222526
• Was Device Available for Evaluation?: No
• 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: 07/29/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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: Required Intervention
• Patient Sex: Unknown