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

Model Number	405154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During the implantation procedure, a pneumothorax occurred.When puncturing the subclavien vein in preparation for probe insertion for the crt-d system, a pneumothorax occurred.A pleural drainage was administered to stabilize 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 pneumothorax could not be conclusively determined.
Event or Problem Description
There were no performance issues with any abbott device.

• Brand Name: PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8429954
• Report Number: 3005334138-2019-00148
• Device Sequence Number: 192882
• Product Code: DYB
• UDI-Device Identifier: 05414734204415
• UDI-Public: 05414734204415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K791129
• 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,Followup
• Report Date (Section B): 03/22/2019

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: 09/30/2021
• Device Model Number: 405154
• Device Catalogue Number: 405154
• Device Lot Number: 6673994
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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: Other