MAUDE Adverse Event Report: ST. JUDE MEDICAL BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM; INTRODUCER, CATHETER

Model Number G407371

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation concluded that the sheath passed pressure and aspiration leak testing with no anomalies observed.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.The cause of the reported air embolism remains unknown.

Event Description

Related manufacturing ref 2182269-2017-00089.During the procedure, an air embolism occurred.The patient had st elevation after contrast agent was injected.The introducer was inserted and the patient became hypotensive and went into cardiac arrest.Air was removed from the patient and sinus rhythm was restored.The procedure was cancelled and the patient was transferred to the icu.

Event Description

Related manufacturing ref 2182269-2017-00089.During a cryo pulmonary vein isolation procedure, an air embolism occurred.The patient had st elevation when contrast agent was injected into the right coronary artery and a diagnostic catheter was inserted.After both introducers were inserted, the patient became hypotensive, lost consciousness, and went into cardiac arrest.A cardiac massage was performed and sinus rhythm was restored.The patient regained consciousness and was transferred to the icu.

• Brand Name: BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6813513
• MDR Text Key: 83432883
• Report Number: 3005334138-2017-00117
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052644
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: G407371
• Device Lot Number: 5979007
• Other Device ID Number: 05414734216524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• 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: AGILIS¿ STEERABLE INTRODUCER (G408318, 5951032); INQUIRY OPTIMA CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR