MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE IDEAL¿; INTRODUCER, CATHETER

Catalog Number PID7F23021SC/C

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a catheterization procedure, the access wire detached and sheared off while removing the inner dilator after sheath placement.No patient injury to report.A new device was used to complete the procedure.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and the complaint was confirmed.A root cause could not be determined.A review of the device history record was performed and no similar complaints for this lot number were identified and no exception documents were found.

• Brand Name: PRELUDE IDEAL¿
• Type of Device: INTRODUCER, CATHETER
• 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: 17680514
• MDR Text Key: 323171521
• Report Number: 1721504-2023-00069
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884450684245
• UDI-Public: 00884450684245
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: PID7F23021SC/C
• Device Lot Number: H2665857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1