MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SURFACER® INSIDE-OUT®; REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM

Catalog Number	600200/C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemothorax (1896)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not been returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.No lot number was provided; thus, the device history record could not be reviewed and a search of the complaint database could not be performed.
Event or Problem Description
In a literature article (bohle et al., 2023), customer reports "a 71-year-old female undergoing surfacer inside-out central venous catheter placement for thoracic central venous occlusion experienced a near-fatal arterial injury.During advancement of the device, the right internal mammary artery was inadvertently lacerated, resulting in massive bleeding and cardiovascular collapse.The patient required transfusion, chest tube placement, and coil embolization of the injured artery.Imaging review post-procedure revealed the trajectory of the device intersected the artery, indicating potential for injury due to anatomical variation.The event resulted in hemothorax and prolonged hospitalization, but the patient ultimately recovered.".

• Brand Name: SURFACER® INSIDE-OUT®
• Common Device Name: REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23645271
• Report Number: 1721504-2025-00623
• Device Sequence Number: 9829840
• Product Code: QJH
• UDI-Device Identifier: 00884450762158
• UDI-Public: 00884450762158
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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 Catalogue Number: 600200/C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female