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

Catalog Number PSI-6F-11-035-18G/BR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 07/06/2023

Event Type  Injury  

Event 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.

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®
• Type of Device: 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
• MDR Text Key: 326958916
• Report Number: 1721504-2023-00050
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00884450011393
• UDI-Public: 00884450011393
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K070159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: PSI-6F-11-035-18G/BR
• Device Lot Number: A701322
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention