MAUDE Adverse Event Report: ABBOTT MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407362
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, when inserting the sheath into the patient¿s body after puncture, blood leaked from the hemostasis valve.The dilator, guidewire, and catheter were inserted into the valve and, the blood leak occurred immediately after the catheter was inserted into the patient¿s body.No resistance was noted with the first device inserted into the sheath¿s hemostatic valve.The introducer was replaced, and the procedure was completed with no adverse consequences to the patient.No air movement into the patient was confirmed.No additional puncture at the access site was necessary during sheath replacement.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h11.One 8.5f swartz braided introducer sheath was received for evaluation.Functional testing determined a leak was noted in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.A puncture was noted in the proximal seal.Tearing, resulting in a hole, was noted in the proximal and distal seals.A corrective action was initiated to address the failure mode of the swartz braided introducer leak.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F
• 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: 22193968
• Report Number: 3005334138-2025-00335
• Device Sequence Number: 9274850
• Product Code: DYB
• UDI-Device Identifier: 05414734205573
• UDI-Public: (01)05414734205573(10)10436127(17)270630
• 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,Followup
• Report Date (Section B): 07/10/2025

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 Model Number: 407362
• Device Catalogue Number: 407362
• Device Lot Number: 10436127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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
• Patient Sex: Unknown