MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT MAK¿; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	00884450012598
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that while using fluoroscopy, the tip of the guidewire was detached during insertion into the vein with echo-guide.Resistance was felt, and the tip detached within the hypodermal tissue.The tip was removed from the patient's body.No injury to report.
Additional Manufacturer Narrative
The suspect device was 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 MAK¿
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12961460
• Report Number: 3011642792-2021-00026
• Device Sequence Number: 14808643
• Product Code: DRE
• UDI-Device Identifier: 00884450012598
• UDI-Public: 00884450012598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 05/21/2024
• Device Model Number: 00884450012598
• Device Catalogue Number: MAK401N-E/C
• Device Lot Number: I2109118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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 Sex: Unknown