MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. - PEARLAND RESOLVE; CATHETER, IRRIGATION

Model Number	00884450009857
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
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 during a drainage tube removal procedure, the biliary drainage tube detached within the patient biliary system.An attempt to retrieve the foreign body from the patient was not made.The account believes that the detached piece will naturally pass through the patient's gi track and will be naturally discharged.No patient injury to report.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could be related to use error of the device for biliary-related procedures.[per ifu] the drainage catheter is not to be used within the biliary system.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: RESOLVE
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. - PEARLAND; 14646 kirby drive; houston TX 77047
• MDR Report Key: 10741825
• Report Number: 3010665433-2020-00043
• Device Sequence Number: 16942830
• Product Code: GBX
• UDI-Device Identifier: 00884450009857
• UDI-Public: 00884450009857
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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 Model Number: 00884450009857
• Device Catalogue Number: RLC-12-038MB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1