MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH; INTRODUCER, CATHETER

Model Number G408318

Device Problem Air Leak (1008)

Patient Problem Embolus (1830)

Event Date 12/12/2017

Event Type  Injury  

Event Description

Related manufacturer report number: 3005334138-2018-00012.During an ablation procedure, air was visualized in the left ventricle.After the catheters were inserted into the sheaths an x-ray revealed air in the left ventricle.The air was attempted to be aspirated but with no resolution.The introducers were replaced and the procedure was completed with no adverse consequences to the patient.After the procedure, an mri confirmed there was no air in the heart or blood vessels.

Manufacturer Narrative

The device was returned due to air in the left ventricle.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.The cause of the reported leak remains unknown.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7179156
• MDR Text Key: 96868176
• Report Number: 2182269-2018-00008
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/31/2018

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 Expiration Date: 05/31/2020
• Device Model Number: G408318
• Device Catalogue Number: G408318
• Device Lot Number: 6044583
• Other Device ID Number: 05414734206112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• 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
• Treatment: FLEXABILITY SE; REFLEXION SPIRAL; SWARTZ INTRODUCER; VIEWFLEX CATHETER
• Patient Outcome(s): Required Intervention