MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE® PRO; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	10884450330323
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that while gaining sheath access for an rf ablation procedure of the gsv, the introducer hub detached within the 7f access sheath.The attending clinician and staff did not recognize that the introducer had detached from the hub while removing the access wire and introducer together as the last step of the seldinger access technique.When the clinician was introducing the rf ablation catheter through the access sheath, they inadvertently introduced the foreign body into the patient's iliac vein.The clinician could not identify the foreign body via us.The patient was transferred to another facility for better imaging where the location of the foreign body was confirmed.Vascular surgery was then consulted, and the foreign body successfully extracted via surgical technique thus liberating the needed vascular conduit for the patient.
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and 2 similar complaints for this lot number have been identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: PRELUDE® PRO
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 13862525
• Report Number: 1721504-2022-00024
• Device Sequence Number: 14657502
• Product Code: DRE
• UDI-Device Identifier: 10884450330323
• UDI-Public: 10884450330323
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K070159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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 Expiration Date: 09/07/2024
• Device Model Number: 10884450330323
• Device Catalogue Number: PRO-7F-11-018NT7/C
• Device Lot Number: H2220117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown