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

Catalog Number	PSI-6F-11-035-18G/BR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that when using the product for puncture, it is not flexible and damaged the artery due to its rigidity.No additional information available.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

• 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: 18038416
• Report Number: 1721504-2023-00050
• Device Sequence Number: 15523275
• Product Code: DRE
• UDI-Device Identifier: 00884450011393
• UDI-Public: 00884450011393
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: PSI-6F-11-035-18G/BR
• Device Lot Number: A701322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown