MAUDE Adverse Event Report: MERIT MEDICAL DO BRASIL PRELUDE®; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	PSI-5F-11-018/BR
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
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
The account alleges that the tip of the guidewire in the introducer kit broke.No patient injury to report.
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.

• Brand Name: PRELUDE®
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL DO BRASIL; rua dona francisca; 8.300 - bloco 10 módulo e; joinville, santa catarina 89219 -600; BR 89219-600
• Manufacturer (Section G): MERIT MEDICAL DO BRASIL; rua dona francisca; 8.300 - bloco 10 módulo e; joinville, santa catarina 89219 -600; BR 89219-600
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 16314100
• Report Number: 1721504-2023-00012
• Device Sequence Number: 17582320
• Product Code: DRE
• UDI-Device Identifier: 00884450011393
• UDI-Public: 00884450011393
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 08/31/2024
• Device Catalogue Number: PSI-5F-11-018/BR
• Device Lot Number: A701186
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown