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

Model Number	00884450012635
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that when using a micro-puncture kit for non-vascular procedural access, the sheath tip just below the radiopaque marker band detached within the patient's common bile duct.The sheath's introducer was easily removed from the sheath with no resistance.The physician passed an.035 amplatz extra stiff guidewire through the sheath, and was attempting to remove the sheath from the patient when the sheath tip detached.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint was confirmed, however the root cause could not be established.A review of the device history record was performed, and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number 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: 10283495
• Report Number: 3011642792-2020-00008
• Device Sequence Number: 11476493
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 00884450012635
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• 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): 07/03/2020

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: 02/20/2023
• Device Model Number: 00884450012635
• Device Catalogue Number: MAK-NV-002/A
• Device Lot Number: I1777902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1