MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407453

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

One 8.5f swartz braided introducer sheath and dilator were received for evaluation.The dilator was perforated at 1.49¿ and 1.58¿ proximal to the distal tip.The sheath was also perforated at 0.21¿ and 0.31¿ proximal to the distal tip.A needle/stylet assembly from current inventory was inserted and advanced through the dilator; however, the needle could not advance past the location of the dilator perforations.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath and dilator perforation remain unknown.

Event Description

This report is to advise of a perforation on the introducer and dilator found during analysis.During the procedure, the physician was unable to put the needle inside the sheath.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.A stylet was used and the needle was not reshaped.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F
• 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: 15258451
• MDR Text Key: 299405550
• Report Number: 3005334138-2022-00479
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: 05414734205771
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052644
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 8311954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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