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

Catalog Number	PLS-2511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemothorax (1896)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
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 and complaint database cannot be performed as a lot number was not provided.
Event or Problem Description
On (b)(6) 2025, a merit employee conducted a pmcf review for the prelude snap product family.A prelude snap splittable sheath introducer was used to treat a female patient for the introduction of secondary device (e.G., pacing leads, catheters) into the heart or coronary venous system.The primary usage of the device was to facilitate placement of a device in the left ventricle through the subclavian vein.The device was used for approximately 25 minutes.During this time the patient experienced a pneumothorax.No additional treatment was required no additional information is available at this time.

• Brand Name: PRELUDE SNAP SPLITTABLE SHEATH INTRODUCER
• Common Device Name: SPLITTABLE SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana in?s de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• 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: 22647398
• Report Number: 1721504-2025-00215
• Device Sequence Number: 8632499
• Product Code: DYB
• UDI-Device Identifier: 00884450468159
• UDI-Public: 00884450468159
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PLS-2511
• 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: 07/11/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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