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

Model Number 405154

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 09/14/2020

Event Type  Injury  

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 Description

Related manufacturer report numbers: 3005334138-2020-00457.Following an lv implant procedure, during follow-up in the clinic, a pneumothorax was seen on the left lung of the patient.The patient was hospitalized and remained in good condition.There were no performance issues with any abbott devices.

• Brand Name: PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10669557
• MDR Text Key: 211052220
• Report Number: 3005334138-2020-00458
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734204415
• UDI-Public: 05414734204415
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K894431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 405154
• Device Catalogue Number: 405154
• Device Lot Number: 7297434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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
• Treatment: PEEL AWAY
• Patient Outcome(s): Other