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

Model Number	00884450088838
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not 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 percutaneous nephrostomy tube placement procedure on an elderly female patient, a micropuncture access guidewire tip detached.The physician was attempting non-vascular access with eco/fluoroscopic guidance at the lower calyx of the kidney.During wire manipulations through an access needle, 4cm of the distal 0.018 guidewire detached.The detached fragment of the non-vascular access wire remains within the patient's kidney.A post-procedural computed tomography [ct] scan was performed.Considering the health conditions of the patient and the existing comorbidities, the medical staff decided not to attempt to retrieve the foreign body fragment from the patient.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.Photographs of the used device were reviewed.The complaint was 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 MINI ACCESS KIT
• Common Device Name: ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego,, ca
• MDR Report Key: 9799391
• Report Number: 3011642792-2020-00004
• Device Sequence Number: 10957056
• Product Code: GCB
• UDI-Device Identifier: 00884450088838
• UDI-Public: 00884450088838
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 11/30/2021
• Device Model Number: 00884450088838
• Device Catalogue Number: MAK-NV-016/A
• Device Lot Number: I1570906
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1