MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F; INTRODUCER, CATHETER

Model Number	405112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
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 incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 3005334138-2020-00123.During a crt-d implant procedure, the subclavian vein was perforated.When access to the subclavian vein was being performed, several punctures were required but were not successful.The vein was perforated several times and the patient's condition worsened with blood noted to be coming from the mouth.The patient was intubated and required ventilation support, eventually being transferred to the surgical operating room in unstable condition.Open chest surgery was required to stop the bleeding.There were no performance issues with any abbott device.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9884933
• Report Number: 3005334138-2020-00124
• Device Sequence Number: 2896713
• Product Code: DYB
• UDI-Device Identifier: 05414734204125
• UDI-Public: 05414734204125
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 06/30/2022
• Device Model Number: 405112
• Device Catalogue Number: 405112
• Device Lot Number: 7081015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention