MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406851
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an af ablation procedure, the sheath separated from the hub while inside the patient.The device was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.The hemostasis hub of the introducer was detached from the sheath tubing.Dissection of the hemostasis hub revealed all components of the hemostasis hub were present and met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the hemostasis hub detachment is consistent with damage during use.

• Brand Name: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES 63 CM LE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11403968
• Report Number: 3005334138-2021-00144
• Device Sequence Number: 3372788
• Product Code: DYB
• UDI-Device Identifier: 05414734203401
• UDI-Public: 05414734203401
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Expiration Date: 06/30/2023
• Device Model Number: 406851
• Device Catalogue Number: 406851
• Device Lot Number: 7598347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1