MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MICROCATHETER MERIT MAESTRO; MICRO CATHETERS

Catalog Number 28MC24130ST/D

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a celiac artery embolization while attempting to manipulate the microcatheter within the patient, the radiopaque marker band detached within the patient's tortuous anatomy.The physician successfully externalized the foreign body with a vascular snare device liberating the vessel.The embolization procedure was completed without additional consequences to the patient.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.

• Brand Name: MICROCATHETER MERIT MAESTRO
• Type of Device: MICRO CATHETERS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SUSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15009070
• MDR Text Key: 295860295
• Report Number: 1721504-2022-00058
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00884450357958
• UDI-Public: 884450357958
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K082613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28MC24130ST/D
• Device Lot Number: H2170678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER.; GUIDEWIRE.
• Patient Outcome(s): Required Intervention