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 Flaked (1246)

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

During a left atrial appendage occlusion procedure, following the transseptal puncture, a thread was observed on the introducer in the left atrium on trans-esophageal echocardiogram.An activated clotting time was performed and the sheath was aspirated in order to pull the piece back into the introducer that appeared to be on the tip.The part was then thought to be a part of plastic from the sheath.The activated clotting time was 280 and no clot was detected.A stylet was used with the needle, however, the needle was pre-shaped prior to insertion.The introducer was exchanged and the procedure was completed with no adverse consequences to the patient.There were no insertion difficulties noted with the needle.The piece of material was not free floating in the left atrium and was only on the tip.It was not able to be confirmed whether this was the only plastic thread from the incident.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One 8.5f fast-cath introducer sheath was received for evaluation.Visual inspection revealed the sheath distal tip had been split and ben and was kinked 7.66¿ proximal to the distal tip.The sheath had been split and bent at the distal tip; however, no missing material was noted.Information from the field stated that the needle had been pre-shaped.The brk needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported "thread was observed on the introducer" could not be conclusively determined.

• 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: 13592544
• MDR Text Key: 286649448
• Report Number: 3005334138-2022-00144
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406849
• Device Catalogue Number: 406849
• Device Lot Number: 8152581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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