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

Catalog Number	PHR6F23021PW/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
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 no exception documents were found.Corrective actions are in process.
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 while attempting radial artery access for a percutaneous coronary intervention [pci] procedure, the introducer hub detached when removing the vascular access guidewire and sheath introducer after acquiring successful vascular sheath access.The remaining introducer was successfully removed from the lumen of the sheath with a pair of hemostats.The sheath was successfully used for the pci procedure.No patient injury to report.

• 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 84095
• MDR Report Key: 9501079
• Report Number: 1721504-2019-00103
• Device Sequence Number: 16613949
• Product Code: DYB
• UDI-Device Identifier: 00884450289389
• UDI-Public: 00884450289389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140543
• 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): 11/22/2019

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: 09/30/2021
• Device Catalogue Number: PHR6F23021PW/C
• Device Lot Number: H1412171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1