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

Catalog Number	PID7F11018NTPD
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during an ecmo procedure, the medical staff noticed an acute change in distal perfusion within the patient's leg.Both near-infrared spectroscopy [nirs] and capillary refill testing indicated a decrease in the distal perfusion line even though the perfusion line appeared patent.The attending physician evaluated the patient's leg and even though the patient was improving, the physician felt that the best course of action was to remove the ecmo support.The patient was removed from ecmo support and upon inspection of the distal perfusion cannula, it appeared to be patent and still intact however, there was a large kink in the middle of the cannula that may have impeded some blood flow during the ecmo procedure.The patient required a leg amputaiton.No additional information to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The most probable cause of this occurrence is forces imposed upon the device during clinical use.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: PRELUDE IDEAL¿
• Common Device Name: 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: 19181174
• Report Number: 1721504-2024-00026
• Device Sequence Number: 15240620
• Product Code: DYB
• UDI-Device Identifier: 00884450684603
• UDI-Public: 00884450684603
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K173750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PID7F11018NTPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Disability
• Patient Sex: Unknown