MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC INTRODUCER INTRODUCER, CATHETER

Model Number MDT-INTRODUCER

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

Patient Problem Pneumothorax (2012)

Event Date 02/02/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure the patient experienced pneumothorax.  the pneumothorax was treated with endothoracic drainage. Pulmonary expansion was achieved and the patient was stable. The suspected cause was the was iatrogenic during subclavian access with the introducer. No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14494598
• Report Number: 2182208-2022-01698
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MDT-INTRODUCER
• Device Catalogue Number: MDT-INTRODUCER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Outcome(s): Required Intervention