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

Model Number	405108
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005334138-2022-00371
• Device Sequence Number: 4813289
• Product Code: DYB
• UDI-Device Identifier: 05415067040879
• UDI-Public: 05415067040879
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown