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

Catalog Number	PLS-1007/CNA
Medical Device Problem Codes	Unsealed Device Packaging (1444); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that seal of the packaging was open.No patient injury to report.
Event or Problem Description
Initial information was captured incorrectly.Actual reported event is "during the implantation of the pacemaker lead, the practitioner found that the introducer sheath had been torn and was unusable after attempting to rinse it.After replacing it with a new introducer sheath, the surgery was completed." upon further review it is determined this is not a reportable complaint due to no patient injury and the device was not used.
Additional Manufacturer Narrative
Initial information was captured incorrectly.Actual reported event is "during the implantation of the pacemaker lead, the practitioner found that the introducer sheath had been torn and was unusable after attempting to rinse it.After replacing it with a new introducer sheath, the surgery was completed." upon further review it is determined this is not a reportable complaint due to no patient injury and the device was not used.

• Brand Name: PRELUDE SNAP¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22909990
• Report Number: 1721504-2025-00178
• Device Sequence Number: 9130803
• Product Code: DYB
• UDI-Device Identifier: 10884450251505
• UDI-Public: 10884450251505
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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
• Device Catalogue Number: PLS-1007/CNA
• Device Lot Number: I3189542
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown