MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE; PERCUTANEOUS CATHETER

Model Number	10884450331337
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2020
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 ten days after an angiogram, a lump was found on the right wrist where the angiogram insertion site was located.Ultrasound found a foreign body and then removed.
Additional Manufacturer Narrative
A small sample of the suspect device has been returned for evaluation.The returned device was examined visually and microscopically.The complaint is confirmed.The root cause could not be determined however, it may be attributed to significant force applied to the device during clinical use.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: PRELUDE
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10854040
• Report Number: 1721504-2020-00097
• Device Sequence Number: 11380103
• Product Code: DRE
• UDI-Device Identifier: 10884450331337
• UDI-Public: 10884450331337
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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 Model Number: 10884450331337
• Device Catalogue Number: PSI-5F-7-018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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