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 Difficult to Insert (1316)

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

Event Date 12/16/2020

Event Type  malfunction  

Event Description

Related manufacturing ref: 3005334138-2021-00371, 3005334138-2021-00374 and 3005334138-2021-00376.During the procedure, insertion difficulties were noted and a delay in procedure occurred.The needle could not be advanced through the sheath due to resistance.This was attempted with three additional sheaths unsuccessfully.A fifth sheath was obtained, and the needle was advanced to complete the procedure with no consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported insertion difficulties and subsequent delay remain unknown.

• 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
• MDR Report Key: 11964957
• MDR Text Key: 255112446
• Report Number: 3005334138-2021-00373
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: 05414734205771
• Combination Product (y/n): N
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 7670728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SWARTZ¿ BRAIDED INTRODUCER X3; SWARTZ¿ BRAIDED INTRODUCER X3
• Patient Weight: 112