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

Catalog Number	600200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemothorax (1896); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	11/12/2025
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, 2023), customer reports " during surfacer inside-out central venous recanalization, patient sustained right internal mammary artery laceration with massive hemothorax and cardiovascular collapse; managed with transfusion, chest tube, and arterial coil embolization.Device use intra-procedure implicated; advanced imaging suggested injury risk along projected device path.".

• 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: 23658628
• Report Number: 1721504-2025-00679
• Device Sequence Number: 10055105
• 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): 11/26/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown