MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT MINI ACCESS KIT

Catalog Number	MAK-NV-013/A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a nephrostomy stent implant procedure, the access wire tip detached within the patients left inferior renal pole during wire manipulations.The physician was unsuccessful in retrieving the wire tip with a vascular snare.Prolongation of hospitalization was necessary for continued observation.The physician states that a small piece of the wire was left within the patient's renal collection system.The patient was discharged to home and scheduled for a follow up appointment and possible intervention.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to significant force being applied to the device during use.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 MINI ACCESS KIT
• Common Device Name: ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego, CA 92154
• MDR Report Key: 9242430
• Report Number: 3011642792-2019-00017
• Device Sequence Number: 1645823
• Product Code: DRE
• UDI-Device Identifier: 00884450088838
• UDI-Public: 00884450088838
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 02/28/2022
• Device Catalogue Number: MAK-NV-013/A
• Device Lot Number: I1523606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention