MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE IDEAL; INTRODUCER, CATHETER

Catalog Number	PID6F11018SS/KRA
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that at the conclusion of the procedure, the physician attempted to remove the sheath from the patient's artery but had difficulty and failed.The patient had an additional procedure the following morning to remove the sheath, which was done successfully.It was noted during removal that the sheath was embedded in the artery.There is no additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually and evidence of clinical use was present.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was 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 IDEAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12513221
• Report Number: 1721504-2021-00067
• Device Sequence Number: 3695796
• Product Code: DYB
• UDI-Device Identifier: 00884450381830
• UDI-Public: 884450381830
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2024
• Device Catalogue Number: PID6F11018SS/KRA
• Device Lot Number: H2074669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: Hospitalization; Life Threatening; Required Intervention