MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS PERIPHERAL CATHETER

Model Number	00884450038048
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
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 the tip of the catheter detached within the patient.The physician was able to remove the detached portion with another catheter using a "stovepipe" method to encapsulate the tip within a new catheter.No patient injury was reported.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9575031
• Report Number: 3010665433-2020-00002
• Device Sequence Number: 16860388
• Product Code: DQO
• UDI-Device Identifier: 00884450038048
• UDI-Public: 00884450038048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450038048
• Device Catalogue Number: 412538BER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 01/10/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention