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

Catalog Number PID6F11021SSC/A

Device Problems Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12137848
• MDR Text Key: 260687131
• Report Number: 1721504-2021-00050
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: 884450381861
• Combination Product (y/n): N
• PMA/PMN Number: K173750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention