MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MAK-NV¿. MICROPUNCTURE KIT; NEEDLE, CATHETER

Catalog Number	MAK-NV-012/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return 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.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that during access for nephrostomy catheter placement, a puncture of the renal pelvis was performed with a micropuncture set.The access procedure was complicated for the clinician.The micro-mandrel access wire was passed through the microneedle down into the urethra.The needle was then removed, and the accompanying catheter was passed over the mandrel/microwire.It was then observed that the soft part of the access micro-wire tip (distal end) had detached within the patient's urethra.Not much manipulation of the wire [mandible] was performed.The detached tip was removed with a snare device.No additional patient consequences to report.

• Brand Name: MAK-NV¿. MICROPUNCTURE KIT
• 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 bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18007975
• Report Number: 3011642792-2023-00070
• Device Sequence Number: 18009708
• Product Code: GCB
• UDI-Device Identifier: 00884450088821
• UDI-Public: 884450088821
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 10/18/2023

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 Catalogue Number: MAK-NV-012/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS NEEDLE; ACCESS SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown