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

Model Number 10884450317515

Device Problem Unclear Information (4052)

Patient Problem Inflammation (1932)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that on (b)(6) 2020 a recent case of aseptic granulomas had been identified possibly involving the hydrophilic coating of a vascular access sheath 4-5 days post-catheterization procedure.The lesions are benign and are slow in healing.The patient has been administered an oral corticosteroid medication post-blood culture result.

• Brand Name: PRELUDE IDEAL SHEATH
• Type of Device: HYDROPHILIC VASCULAR SHEATH
• 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: 10687298
• MDR Text Key: 211641512
• Report Number: 1721504-2020-00086
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10884450317515
• UDI-Public: 10884450317515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10884450317515
• Device Catalogue Number: PID6F11025PW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention