MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number 407451

Device Problems Entrapment of Device (1212); Material Frayed (1262)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Related manufacturer ref: 3005334138-2021-00712.During an atrial fibrillation, when attempting to remove the mapping catheter from the introducer, it became stuck.It was then attempted to remove both the mapping catheter and introducer at the same time, but the two could not be removed.The incision was enlarged at the vascular site and the catheter and introducer were then able to be removed.Upon removal, both the catheter and introducer were noted to be torn and bent at the tips.The procedure was continued as the mapping portion was completed.

Manufacturer Narrative

One 8.5f swartz braided introducer sheath was received for evaluation.The sheath tubing and had been torn, bent and flared at the distal tip; the braided wires and marker band had been fractured at the tear location.The sheath hemostasis cap inside diameter measurement was within specifications and no anomalies were noted when a dilator from current inventory was inserted and withdrawn.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported withdrawal difficulty remains unknown.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F
• 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: 12866733
• MDR Text Key: 281275583
• Report Number: 3005334138-2021-00711
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052644
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 407451
• Device Lot Number: 8082201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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
• Patient Outcome(s): Required Intervention