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 Date 04/29/2021

Event Type  malfunction  

Event Description

During the procedure, the needle was difficult to advance through the sheath and seemed to be catching.When the sheath was removed/exchanged, it was noted that the needle punctured a hole in the introducer.

Manufacturer Narrative

One 8.5f swartz braided introducer sheath and dilator were received for evaluation.The dilator and sheath had been perforated proximal to the distal tip.A needle/stylet assembly from current abbott inventory was inserted and advanced through the dilator/sheath assembly; however, the needle could not be advanced past where the perforation was located.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the perforation remains 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: 11856533
• MDR Text Key: 252433398
• Report Number: 3005334138-2021-00345
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 7842684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR