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

Model Number	10884450289430
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
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 while attempting to acquire percutaneous transluminal access via seldinger technique, when the introducer hub detached.Vascular access with the 7f introducer sheath was attempted through the patient's right radial artery over an.021 access wire.The physician was attempting to remove both the introducer, and the introducer access wire together from the introducer sheath, when the hub detached leaving the remaining introducer within the sheath.The remaining introducer was removed by the physician.A new access sheath was place and the procedure successfully completed with no additional consequences to the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.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 one exception documents were found.Corrective actions are in process.

• 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: 9920870
• Report Number: 1721504-2020-00022
• Device Sequence Number: 16982806
• Product Code: DYB
• UDI-Device Identifier: 10884450289430
• UDI-Public: 10884450289430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150257
• 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): 03/09/2020

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: 12/31/2020
• Device Model Number: 10884450289430
• Device Catalogue Number: PHR7F11021SC/C
• Device Lot Number: H1383885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1