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

Model Number 408309

Device Problem Gas/Air Leak (2946)

Patient Problems Air Embolism (1697); Death (1802)

Event Date 10/01/2018

Event Type  Death  

Event Description

Three days following a pulmonary vein isolation ablation procedure the patient expired.At the start of the procedure there was difficulty performing the transseptal puncture due to tortuous patient anatomy in the abdomen.Additionally, following transseptal puncture, there was difficulty inserting the introducer guidewire through the puncture site.A new sheath set was used to gain access and perform mapping.Mapping in the left pulmonary veins (pvs) was carried out successfully but due to the size of the patient's atrium, mapping of the right pvs proved to be more challenging and the ablation catheter was exchanged.While maneuvering the agilis with a guidewire in place to map the right sided veins, there was a sudden drop in respiratory rate along with inferior st elevation.Air was visualized in the sheath tube at this time and the sheath was immediately retracted into the right atrium and inferior caval vein.Air was aspirated from the lv and resuscitation efforts were conducted for over 90 minutes.Following resuscitation a coronary angiography displayed no evidence of residual air or any other irregularities in the coronary arteries.The patient remained intubated and was transferred to the icu.The patient expired three days later.

Manufacturer Narrative

One agilis steerable introducer sheath was received for evaluation.Functional testing of the device revealed a leak within the handle.The handle was opened and the pull wire windows were noted to be torn, consistent with the leak detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the shaft window damage is consistent with torque being applied to the handle while the shaft was constrained, maneuvering and deflecting of the sheath with an unsupported shaft, and damage during use.The agilis nxt steerable introducer instructions for use, cautions ¿indwelling percutaneous introducer sheaths should always be supported with a catheter or an obturator.¿.

• 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, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 7959872
• MDR Text Key: 123496919
• Report Number: 3008452825-2018-00348
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: 05414734206099
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 6466350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• 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): Death
• Patient Age: 66 YR