MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F; INTRODUCER, CATHETER

Model Number 405108

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 06/17/2022

Event Type  Injury  

Event Description

During the implantation of a single-chamber pacemaker with an electrode in the atrial location, an air embolism was noted.When the tendril electrode was inside the introducer, the entry of air through the sheath was observed.Followed by an immediate decompensation of the patient with oxygen saturation below 80% and a blood pressure of 90/50.Vasoactive drugs were administered which stabilized the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported air leak could not be conclusively determined.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14804305
• MDR Text Key: 294882445
• Report Number: 3005334138-2022-00371
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05415067040879
• UDI-Public: 05415067040879
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K894431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 405108
• Device Catalogue Number: 405108
• Device Lot Number: 8423242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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): Life Threatening