MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD MAK-NV; NEEDLE, CATHETER

Model Number	00884450013601
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has not yet returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during bile duct access under fluoroscopy with a micropuncture access kit, the tip of the access wire unraveled and detached within the intrahepatic bile duct of the patient.
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: MAK-NV
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; houston, ; EI
• MDR Report Key: 9920865
• Report Number: 9616662-2020-00006
• Device Sequence Number: 11467599
• Product Code: GCB
• UDI-Device Identifier: 00884450013601
• UDI-Public: 00884450013601
• Combination Product (Y/N): N
• 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): 03/04/2020

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: 09/19/2021
• Device Model Number: 00884450013601
• Device Catalogue Number: MAK-NV-002/CNA
• Device Lot Number: I1429315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1