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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, a pneumothorax occurred which required resuscitation.During implantation, the patient¿s vital signs and oxygen saturation became poor.The anesthesiologist asked that the operation be interrupted to stabilize the patient.When the cs was visualized, using the balloon catheter, contrast medium entered the entire heart.An ultrasound was used to see where the problem was.The patients blood pressure dropped and a pneumothorax was noted.An attempt was made to correct the pneumothorax with help of a drainage.The patient required resuscitation, the physicians began chest compressions, and the patient was transferred to intensive care unit under the accompaniment of the internal rescue team and the procedure was aborted.It was noted that the pneumothorax likely occurred during puncture of the subclavian vein.
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 pneumothorax remains unknown.

• 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: 18807372
• Report Number: 3005334138-2024-00068
• Device Sequence Number: 7231808
• Product Code: DYB
• UDI-Device Identifier: 05415067040879
• UDI-Public: 05415067040879
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230283, K79
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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 Expiration Date: 10/31/2025
• Device Model Number: 405108
• Device Catalogue Number: 405108
• Device Lot Number: 8755123
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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: Required Intervention
• Patient Sex: Unknown