MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT S-MAK¿.COAXIAL MINI ACCESS KIT

Model Number	00884450012635
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number has been provided and a review of the manufacturing history record is in progress.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous vascular access attempt for a 70yo male patient diagnosed with venous thrombosis (cvt), the primary access wire was unable to be retrieved from the patient's left femoral artery by the physician assistant [pa].Direct pressure was held at the femoral access site awaiting the attending physician's arrival for assistance.The physician was involved in another procedure at the time.When the physician arrived, secondary access was successfully acquired, via a new micropuncture access wire.A sheath was placed in the patient's right femoral artery in order to acquire multiple angiographic views [x4] of the patient's left femoral arterial system.The physician attempted to remove the entrapped primary access wire but only part of the access wire was successfully retrieved from the patient.The medical staff made the decision to complete the ablation procedure with the foreign body still entrapped within the left femoral artery.
Additional 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: MERIT S-MAK¿.COAXIAL MINI ACCESS KIT
• Common Device Name: MERIT S-MAK¿
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17253099
• Report Number: 3011642792-2023-00047
• Device Sequence Number: 3584666
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 00884450012635
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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 Expiration Date: 11/15/2025
• Device Model Number: 00884450012635
• Device Catalogue Number: S-MAK401N/C
• Device Lot Number: I2549433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male