MAUDE Adverse Event Report: Abbott Medical Swartz¿ Braided Transseptal Guiding Introducer, SL0¿, 63 cm Length, 8.5 F; Introducer, Catheter

Model Number	407451
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721); Stroke/CVA (1770)
Date of Event	08/25/2026
Type of Reportable Event	Death
Event or Problem Description
During a pfa procedure, air ingress, st elevation, bradycardia, and cerebral hypoxia occurred which resulted in the patient transferring to the icu and receiving hyperbaric therapy twice.The patient later passed away in the neurology icu.For the procedure, the patient was sedated with fentanyl and remimizolam.The transseptal puncture progressed normally with a jump to fosa ovalis and an expected ibp curve form for la pressure.After the transseptal puncture, the sl0 guidewire was placed in the lspv of the left atrium.The dilator and sl0 sheath were removed from the patient.The agilis 13f and dilator were then advanced over the sl0 guidewire into the ivc.However, resistance was felt before reaching the heart.Fluoroscopy noted that the sl0 guidewire was kinked below the diaphragm.The agilis 13f and dilator were removed from the ivc.The sl0 sheath and dilator were flushed, re-assembled, and re-inserted into the ivc along the guidewire.The sl0 and dilator also could not pass the kinked guidewire.The sl0 and dilator were removed again.The sl0 sheath was flushed again, and only the sl0 sheath was advanced over the guidewire without the dilator.The sl0 was able to advance past the kink on the guidewire all the way into the la.Once the sl0 tip was in the la, the kinked guidewire was removed with resistance out of the sl0 sheath.A new sl0 was opened, and the new guidewire was advanced in the previous sl0 and placed in the lspv.The sl0 was then removed from the la with the new guidewire in place.The agilis 13f sheath and dilator were flushed again with a 20ml luer lock syringe, re-assembled, and placed over the new guidewire into the la.15-20ml of blood was aspirated from the agilis 13f.Then the volt catheter was prepared.The volt catheter was then inserted slowly into the agilis 13f with the handle horizontal at heart level.15ml of blood was then aspirated one the basket had passed the agilis 13f handle into a 20ml luer lock syringe.Then the volt catheter was slowly placed in the la and inflated with 10ml with the stopcock closed.The volt catheter was connected to the unified cable and all icons were green.Shortly before the volt balloon was placed in the left atrium, st elevation and bradycardia were noted on the ecg and the hypotension occurred.A diagnostic catheter was positioned to pace the rv to maintain cardiac output and fluids were given.Echocardiogram was performed multiple times to rule out cardiac tamponade.The st elevation, bradycardia, and blood pressure returned to normal within 10 minutes.The pvi procedure was proceeded with the volt catheter.All four veins were ablated with no issue.However, the patient could not be woken up from sedation and was showing signs of cerebral hypoxia with pronation of extremities.Cerebral ct scans were performed which showed signs of cerebral air embolisms.The patient was transferred to the neurology icu and received hyperbaric therapy twice.The cause for the air embolism is unknown, but the physician alleges it may be due to the multiple exchanges over the sl0 wire.The patient then passed away on 03-sep-2026 in the neurology icu.The ifu was also not followed, which mentions ¿if resistance is met when advancing or withdrawing guidewire or introducer, determine the cause and correct before continuing with this procedure¿ and ¿while inside the body introducer sheaths should be supported with an obturating device.¿.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.The results of the investigation are inconclusive since the device was not returned for analysis.It was noted that devices continued to be inserted when a kinked wire and resistance was noted rather than correcting the cause before continuing.In addition, there was no obturating device when the sheath was inserted alone with no guidewire or dilator when getting the new guidewire for insertion.The swartz braided transseptal guiding introducer instructions for use (ifu) states, ¿if resistance is met when advancing or withdrawing guidewire or introducer, determine the cause and correct before continuing with this procedure¿ and ¿while inside the body introducer sheaths should be supported with an obturating device.¿ review of the batch record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident is consistent with not following the ifu.In addition, the cause of the reported kinked dilator and insertion difficulty could not be conclusively determined.

• Brand Name: Swartz¿ Braided Transseptal Guiding Introducer, SL0¿, 63 cm Length, 8.5 F
• 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: 50889804
• Report Number: 3005334138-2026-00488
• Device Sequence Number: 10712340
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: 05414734205757
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K052644
• 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): 09/24/2026

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: 407451
• Device Catalogue Number: 407451
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization; Death; Required Intervention
• Patient Sex: Unknown