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

Model Number 408310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer report number: 3005334138-2020-00252.During an ablation procedure, a heart block occurred.During ablation in the right atria, the patient became hypotensive.A cardiac ultrasound was performed, but no pericardial effusion was noted.The patient¿s ecg qrs morphology had become broad and periods of av block were occurring, and cpr was started to stabilize the patient.The patient returned to a normal rhythm and blood pressure with no further intervention.There were no performance issues with any abbott devices. .

• Brand Name: AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, MEDIUM CURL, 8.5 F
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10237364
• MDR Text Key: 197853719
• Report Number: 3008452825-2020-00316
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2020

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: 408310
• Device Catalogue Number: 408310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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