MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE SHEATH INTRODUCER

Catalog Number	PSI-6F-11-035-18G/CN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot 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 were identified.
Event or Problem Description
The account alleges that during the operation of the ecmo artificial cardiopulmonary machine, the sidearm tubing of the sheath detached.

• Brand Name: PRELUDE SHEATH INTRODUCER
• Common Device Name: SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22569714
• Report Number: 1721504-2025-00181
• Device Sequence Number: 13066393
• Product Code: DRE
• UDI-Device Identifier: 00884450050729
• UDI-Public: 00884450050729
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: PSI-6F-11-035-18G/CN
• Device Lot Number: H2995859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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
• Patient Sex: Unknown