MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER, SL1 10F; INTRODUCER, CATHETER

Model Number	406969
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, after performing the transseptal puncture and when removing the sheath from the patient to replace it with a non-abbott cryo sheath, the body of the sheath separated from the valve.The sheath body, valve, and dilator were all removed over a wire using standard exchange technique.No intervention was required and all the pieces of the device were accounted for.The planned sheath exchange then occurred and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 10f fast-cath introducer sheath was received for evaluation.The dilator was also received.The hemostasis hub of the introducer was able to rotate freely.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 loose hemostasis hub remains unknown.

• Brand Name: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER, SL1 10F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11700304
• Report Number: 3005334138-2021-00273
• Device Sequence Number: 14364159
• Product Code: DYB
• UDI-Device Identifier: 05414734203579
• UDI-Public: 05414734203579
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 07/31/2023
• Device Model Number: 406969
• Device Catalogue Number: 406969
• Device Lot Number: 7643258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1