MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MAK-NV¿ INTRODUCER SYSTEM; NEEDLE, CATHETER

Model Number	00884450013588
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The account alleges that while placing a nephrostomy tube, the guidewire (2cm piece) detached within the patient anatomy.The patient was transferred to the operating room and the foreign body was successfully removed.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number was identified.Should the device be returned later, the investigation will be reopened.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number was identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: MAK-NV¿ INTRODUCER SYSTEM
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17076195
• Report Number: 3011642792-2023-00042
• Device Sequence Number: 16678549
• Product Code: GCB
• UDI-Device Identifier: 00884450013588
• UDI-Public: 00884450013588
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

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 Expiration Date: 09/20/2025
• Device Model Number: 00884450013588
• Device Catalogue Number: MAK-NV-004/A
• Device Lot Number: I2496078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 07/05/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/06/2023; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown