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 Puncture/Hole (1504)

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

Event Date 12/14/2021

Event Type  malfunction  

Event Description

Related manufacturing ref: 3005334138-2021-00776.During a cryo atrial fibrillation procedure, skiving was noted as well as a puncture of the dilator and sheath in the both devices.The physician was preparing to obtain transeptal access to the left atrium using ice as guidance.While in the right atrium, the needle was inserted into an sl1 sheath.When attempting to advance the needle to the septum, the needle did not advance as expected.The needle was removed and plastic from the sheath/dilator was noted to be occluding the hole at the distal tip of the needle.The sl1 sheath and dilator were removed for inspection and a puncture was noted in both.Both the needle and sheath were replaced and transseptal access was attempted again with the same issue.The brk needle punctured the sl1 sheath and dilator and the hole at the distal tip of the needle was occluded with plastic.The devices were then exchanged for a new sl1 sheath and non abbott needle and the case continued with no consequences to the patient.

Manufacturer Narrative

One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The reported brk needle was also returned; skived material was found at the needle tip.The sheath and dilator had been perforated proximal to the distal tip.A needle/stylet assembly from current inventory was 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.Artmt600087496, ver.A, brk needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the cause of the needle insertion difficulty, skiving and perforation is consistent with altering the shape of the needle.

• 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: 13021817
• MDR Text Key: 282893108
• Report Number: 3005334138-2021-00777
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: 8221900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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
• Treatment: FAST-CATH INTRODUCER SWARTZ SL