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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, the steering knob of the sheath broke and it was unable to deflect correctly.The sheath was replaced and the issue was resolved with no adverse consequences to the patient.When the introducer was replaced, a second femoral puncture was needed.

Manufacturer Narrative

Additional information: b5, g3, h2.Correction: h6.

Event Description

During an atrial fibrillation ablation procedure, the steering knob of the sheath broke and it was unable to deflect correctly.The sheath was replaced and the issue was resolved with no adverse consequences to the patient.No additional femoral puncture was conducted.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was received for evaluation.The dilator was also returned.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.

• 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
• MDR Report Key: 12506902
• MDR Text Key: 272493960
• Report Number: 3008452825-2021-00462
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: 05414734206099
• Combination Product (y/n): N
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 7510125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other