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

Catalog Number	PID6F11018NTPD
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
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 percutaneous transluminal interventional procedure, the hub on the introducer detached within the introducer sheath.The clinician had acquired vascular access [via seldinger technique] with the introducer sheath.During removal of the introducer along with the access guidewire, the introducer sheath hub detached from the introducer leaving the introducer within the access sheath.The clinical was able to save the primary access site and sheath for the chronic total occlusion [cto] procedure by using a vascular snare device that had already been prepped and sitting within the sterile field instead of using a pair of forceps.Retrieval was successful, and the primary access site and sheath were used to complete the cto procedure.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 9857538
• Report Number: 1721504-2020-00016
• Device Sequence Number: 3307312
• Product Code: DYB
• UDI-Device Identifier: 00884450317372
• UDI-Public: 00884450317372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: PID6F11018NTPD
• Device Lot Number: H1740235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/24/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1