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

Catalog Number	PSS-6F-4-018MT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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 when inserted into patient with contrast injection, the 6fr green cap and anti-reflux valve disconnected from the hub of the sheath and blew back onto the wire that was used to maintain access into the vessel.The patient had some blood flowing out from the hub of the sheath but was controlled before significant bleeding could occur and with no significant harm to the patient.The sheath was exchanged and the procedure was completed successfully without any further occurrences or harm to the patient.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and simulated use testing was performed.The complaint is confirmed.Root cause is attributed to the user of the device.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: PRELUDE SHORT SHEATH
• Common Device Name: SHORT SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20127001
• Report Number: 1721504-2024-00062
• Device Sequence Number: 14269349
• Product Code: DYB
• UDI-Device Identifier: 00884450015391
• UDI-Public: 00884450015391
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K082063
• 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,Followup
• Report Date (Section B): 08/29/2024

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: PSS-6F-4-018MT
• Device Lot Number: H2945632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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
• Patient Sex: Unknown