MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE SNAP; INTRODUCER, CATHETER

Model Number 10884450251505

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

Physician noted an issue with the 7fr split-table sheaths for implants.The hemostatic valve is not splitting when the sheath is split leaving the potential for the valve to be left in the pocket.With this patient, physician noticed the malfunction and had to remove the valve manually.

• Brand Name: PRELUDE SNAP
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 10459305
• MDR Text Key: 204544351
• Report Number: 10459305
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10884450251505
• Device Catalogue Number: PLS-1007
• Device Lot Number: I-1842403
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1