MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F; INTRODUCER, CATHETER

Model Number 408309

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Cardiac Perforation (2513)

Event Date 03/30/2022

Event Type  Injury  

Event Description

During a left atrial atypical flutter, a pericardial effusion occurred.During the procedure, the sheath did not deflect as expected.When attempting to steer the ablation catheter to area of interest in the left atrium, the sheath did not deflect as intended in the left atrium.A guidewire was inserted into the left atrium to exchange the broken sheath.At that moment, the anesthesiologist noted a drop in blood pressure and an ice catheter confirmed an effusion.A pericardiocentesis was performed to stabilize the patient.The physician believed the pericardial effusion started from within the left atrium.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 one 8.5f agilis steerable introducer sheath was received for evaluation.The sheath was unable to deflect in one direction due to the detachment of one of the pull wires from the pull ring at the distal end of the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14043559
• MDR Text Key: 288797354
• Report Number: 3008452825-2022-00364
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: 05414734206099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061363
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 8276535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• 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
• Patient Age: 74 MO
• Patient Sex: Male