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

Model Number 407453

Device Problems Flaked (1246); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

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 difficulty and skiving could not be conclusively determined.

Event Description

During an atrial fibrillation ablation procedure, while conducting the transseptal puncture, the brk needle could not be introduced completely into the introducer and the inside of the introducer was then noted to be scratched.Moreover, the needle became stuck at the distal end of the introducer each time.The introducer and brk needle were noted to have been prepared correctly and a stylet was used and the needle was not reshaped.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11135406
• MDR Text Key: 228227159
• Report Number: 3005334138-2020-00652
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 7654590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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