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 Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

One 8.5f fast-cath introducer sheath was received for evaluation.The sheath and dilator had been perforated proximal to the distal tip.The dilator and sheath were flushed with fluid and the dilator was inserted into the sheath; no resistance or anomalies were noted.The returned needle and a stock stylet from current inventory were inserted and advanced through the dilator/sheath assembly; however, the needle could not advance past the location of the perforation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event insertion difficulty and the perforation remains unknown.

Event Description

A report is needed to advise of a perforation found in the sheath during analysis.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18975424
• MDR Text Key: 338601428
• Report Number: 3005334138-2024-00116
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406849
• Device Lot Number: 8989339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1