MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SJ PRELUDE IDEAL¿.6F. SHEATH; INTRODUCER, CATHETER

Catalog Number	PID6F7018NTPD/C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
During the procedure, the doctor realized that the guide was rubbing a little on the patients wrist.The doctor therefore removed it to try to reintroduce it correctly, the guidewire started to unravel.Decision to remove the guide and needle from the wrist of the patient.A new device was used to complete this procedure.Patient.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database and review of the device history record could not be performed as no lot number were provided.

• Brand Name: PRELUDE IDEAL¿.6F. SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SJ; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SJ; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton r.n. ; 1600 merit pky; south jordan, UT 84095 ; 8012665654
• MDR Report Key: 20918261
• Report Number: 1721504-2024-00089
• Device Sequence Number: 8390918
• Product Code: DYB
• UDI-Device Identifier: 10884450518202
• UDI-Public: 10884450518202
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: PID6F7018NTPD/C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown