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	Material Frayed (1262); Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the paroxysmal atrial fibrillation procedure, insertion difficulties resulted in the need for an additional femoral access site.Access was gained in the right groin, and the included guidewire was inserted into the patient.The introducer with the dilator assembled was then advanced over the guidewire.The introducer had been inserted approximately 10cm when further advancement became difficult.Fluoroscopy and ultrasound revealed that the guidewire had kinked at the tip of the dilator.The introducer was withdrawn from the patient, leaving the guidewire in place; however, the kink in the guidewire did not resolve.The guidewire was removed from the patient and determined to be intact.Fraying at the dilator tip was also observed.A linear ultrasound probe had been used but the puncture was performed at a relatively steep angle to the patient, and the vessel course was deeper than usual which is considered a possible contributing factor.The introducer was replaced and a new puncture site was used for insertion.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident 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 ; 6517565400
• MDR Report Key: 25349865
• Report Number: 3005334138-2026-00283
• Device Sequence Number: 16140074
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: (01)05414734205757(10)11198757(17)281231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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
• Device Lot Number: 11198757
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 59 KG