MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE SNAP¿; INTRODUCER, CATHETER

Catalog Number	PLS-1007/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
Customer reports having a couple of prelude snap sheaths not splitting properly and the little valve is falling out into the patient pocket.No patient injury reported.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation, but an image was provided showing the foam cap of the device detached from the hub.Because no scalloping was observed along the edges of the split in the image, a potential root cause is attributed to the incorrect alignment of shape on the machines.Since the device was used and was not returned, the complaint that the device was difficult to split cannot be confirmed.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformance of this nature is monitored by the engineering, quality, and management team members.

• Brand Name: PRELUDE SNAP¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ins de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23017695
• Report Number: 1721504-2025-00333
• Device Sequence Number: 18651404
• Product Code: DYB
• UDI-Device Identifier: 00884450467985
• UDI-Public: 00884450467985
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLS-1007/A
• Device Lot Number: I3261325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 10/06/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown