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

Model Number	10884450317621
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2020
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 during a vascular procedure, the vascular access sheath detached within the patient.The physician had successfully acquired retrograde arterial access and during a catheter exchange, the physician noted that the sheath had detached from its hub.The detached sheath continued to migrate further into the patient's artery while still on the guide wire.The physician was able to then advance a small vascular balloon over the wire, to successfully retrieve the foreign body from the patient.No additional patient consequences to report.
Additional 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.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 HYDROPHILIC INTRODUCER SHEATH
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10371315
• Report Number: 1721504-2020-00057
• Device Sequence Number: 2686865
• Product Code: DYB
• UDI-Device Identifier: 10884450317621
• UDI-Public: 10884450317621
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Expiration Date: 07/31/2022
• Device Model Number: 10884450317621
• Device Catalogue Number: PID6F7018NTPD/A
• Device Lot Number: H1797381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER; GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention