MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE®; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	10884450015107
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
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
Customer reports that during a procedure the sheath fell off the radiopaque tip.No wires or ballons were put through the sheath.It fell off when the sheath was removed.The other sheath after the 0.18 wire was removed it was like the cover on the end of the sheath would not seal.
Additional Manufacturer Narrative
The suspect medical device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: PRELUDE®
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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 ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15638459
• Report Number: 1721504-2022-00104
• Device Sequence Number: 6387168
• Product Code: DRE
• UDI-Device Identifier: 10884450015107
• UDI-Public: 10884450015107
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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 Expiration Date: 06/25/2025
• Device Model Number: 10884450015107
• Device Catalogue Number: PD7F038
• Device Lot Number: H2453253
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown