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	03/17/2020
Type of Reportable Event	Malfunction
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 during percutaneous transluminal access for a chronic total occlusion [cto] procedure, the hub of the 7f introducer detached when the clinician was attempting to remove the access guide wire and the introducer together.The physician was successful in retrieving the detached introducer from the access sheath and continued to use the primary access site to successfully complete the procedure.No patient injury to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually showing evidence of clinical use.The complaint is confirmed.The root cause is attributed to the manufacturing process.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 INTRODUCER SHEATH
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 9972578
• Report Number: 1721504-2020-00025
• Device Sequence Number: 2740241
• Product Code: DYB
• UDI-Device Identifier: 10884450317621
• UDI-Public: 10884450317621
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K173750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 09/30/2022
• Device Model Number: 10884450317621
• Device Catalogue Number: PID7F11021SC
• Device Lot Number: H1750124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1