MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.; INTRODUCER, CATHETER

Model Number 406849

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a procedure, after introducing the sheath into the femoral vein, a loose side port was noted.The sheath was replaced and the procedure was continued with no adverse patient consequences.

Manufacturer Narrative

One fast-cath transseptal guiding introducer swartz sl transseptal series, sl1 8.5f was received for investigation.The reported event of a rotating sheath hub was confirmed.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.

Manufacturer Narrative

The initial report was reported for a loose sideport.One fast-cath¿ transseptal guiding introducer swartz¿ sl transseptal series, sl1¿ 8.5f was received for investigation.The sideport of the introducer met specifications.The hemostasis hub of the introducer was able to freely rotate.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.Since no malfunction was identified with the sideport of the reported device, the event no longer meets reporting criteria as a rotating hub would not likely contribute to serious deterioration in state of health.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8957426
• MDR Text Key: 156396380
• Report Number: 3005334138-2019-00487
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• Combination Product (y/n): N
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 406849
• Device Lot Number: 6851161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 12/03/2019; 01/16/2020
• Supplement Dates FDA Received: 12/26/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1