FDA Adverse Event Malfunction Summary report: N

PRELUDE IDEAL

MDR report key: 11601753 · Received April 1, 2021

Report

Report Number: 11601753
Event Type: Malfunction
Date Received: April 1, 2021
Date of Event: March 29, 2021
Report Date: March 29, 2021
Manufacturer: MERIT MEDICAL SYSTEMS, INC.
Product Code: DYB
UDI-DI: 00884450381861
Product Problem: Yes
Report Source: User Facility report
Reporter Location: OH
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 0

A 49-YEARS OLD PATIENT WITH A HISTORY OF HYPERTENSION, DIABETES MELLITUS, AND CIRRHOSIS WAS ADMITTED WITH A NEW ONSET OF CHEST PAIN. IN THE CATHETERIZATION LABORATORY, A DIAGNOSTIC CATH WAS GOING TO BE PERFORMED WHEN THE TIP OF A PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET BROKE WHEN ATTEMPTING TO INSERT THE DILATOR INTO THE SHEATH. THE BROKEN PIECE WAS NOTICED BY ONE OF THE HEALTH CARE PROVIDERS. MOREOVER, AS SEEN IN THE ATTACHED IMAGES, THE BROKEN PIECE CAUSED THE DEVICE TO HAVE A JAGGED EDGE. THE FAULTY PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET WAS NOT USED ON THE PATIENT.

Description of Event or Problem · 1

A (B)(6) YEARS OLD PATIENT WITH A HISTORY OF HYPERTENSION, DIABETES MELLITUS, AND CIRRHOSIS WAS ADMITTED WITH A NEW ONSET OF CHEST PAIN. IN THE CATHETERIZATION LABORATORY, A DIAGNOSTIC CATH WAS GOING TO BE PERFORMED WHEN THE TIP OF A PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET BROKE WHEN ATTEMPTING TO INSERT THE DILATOR INTO THE SHEATH. THE BROKEN PIECE WAS NOTICED BY ONE OF THE HEALTH CARE PROVIDERS. MOREOVER, AS SEEN IN THE ATTACHED IMAGES, THE BROKEN PIECE CAUSED THE DEVICE TO HAVE A JAGGED EDGE. THE FAULTY PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET WAS NOT USED ON THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
499613	PRELUDE IDEAL	INTRODUCER, CATHETER	DYB	MERIT MEDICAL SYSTEMS, INC.	10884450381868	H2032401	00884450381861

Patients

Seq	Age	Sex	Outcome	Treatment
1	17885 DA