MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE IDEAL HYDROPHILIC SHEATH INTRODUCER

Catalog Number	PID6F11021SSC/A
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2021
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 while accessing the femoral artery using the ideal sheath, the wire went into the artery but the sheath was difficult to advance.The dilator was pulled off the sheath and attempted to insert into the artery.The attempt failed and resulted in the dialator being bent and removed successfully.The groin had a lot of scar tissue and the artery was heavily calcified.Retracting the wire was difficult and is believed to have potentially been caught on calcium.Additional force was applied to the wire in attempt to remove it.The wire separated within the femoral artery.Pressure was held on the groin and a safeguard femoral was placed.The patient was sent by ambulance to the hospital to have the wire surgically removed.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PRELUDE IDEAL HYDROPHILIC SHEATH INTRODUCER
• Common Device Name: SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12137848
• Report Number: 1721504-2021-00050
• Device Sequence Number: 4428613
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: 884450381861
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2024
• Device Catalogue Number: PID6F11021SSC/A
• Device Lot Number: H2094721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/25/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention