MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - MEXICO MAK-NV¿.6F.ACCESS KIT; NEEDLE, CATHETER

Catalog Number	MAK-NV-004/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during an interventional radiology insertion procedure, the mini access guidewire detached during manipulation within the patient's kidney.The foreign body was free floating in the renal pelvis / calyces at the time of removal.It was clinically necessary to remove the foreign body from the patient.No additional patient consequences to report.The procedure was completed successfully.
Additional Manufacturer Narrative
The suspect medical device is expected to return for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.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 were identified.

• Brand Name: MAK-NV¿.6F.ACCESS KIT
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer Contact: bryson heaton rn ; 14646 kirby dr; houston, TX 77047
• MDR Report Key: 20765350
• Report Number: 3011642792-2024-00078
• Device Sequence Number: 18283183
• Product Code: GCB
• UDI-Device Identifier: 00884450013588
• UDI-Public: 884450013588
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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 Catalogue Number: MAK-NV-004/A
• Device Lot Number: I3010335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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