MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERRIT PRECLUDE DEAL SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number REF #PID6F11018NTPD

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  Injury  

Event Description

During replacement of the right radial merrit sheath, we had a failure of the dilator which separated and was freely dislodged in the right radial artery, 6f radial sheath dilator broke off from the hub into the pt's arm.Using a snare we successfully removed the entire dilator, all foreign material removed.Merrit rep has been notified and all sheath equipment secured.Fda safety report id# (b)(4).

• Brand Name: MERRIT PRECLUDE DEAL SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 9823677
• MDR Text Key: 183355196
• Report Number: MW5093695
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: REF #PID6F11018NTPD
• Device Lot Number: H1740235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 64