MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE MERITRANS DTXPLUS®.DTXPLUS¿ DT-4812..STERILE.; SYSTEM, MEASUREMENT,

Catalog Number	682000/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that a 66-year-old patient was hospitalized in an emergency room for cardiac arrest (progressive mi).During use of the pm device, pressure was applied to the radial artery access site.The pm device then fractured/detached at the connection of the radial artery site.No immediate clinical consequences for the patient, but the device was exchanged immediately to prevent blood loss.The device was replaced with a new pm system.The device is available for return.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and a bent pin on the transducer cable was observed.The complaint is confirmed.No definitive root cause could be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: MERITRANS DTXPLUS®.DTXPLUS¿ DT-4812..STERILE.
• Common Device Name: SYSTEM, MEASUREMENT,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21990151
• Report Number: 8020616-2025-00022
• Device Sequence Number: 12859194
• Product Code: DXN
• UDI-Device Identifier: 00884450360538
• UDI-Public: 884450360538
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K935782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 682000/B
• Device Lot Number: C3111318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown