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

Catalog Number	MAK401-E/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
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 transluminal angioplasty procedure, while attempting vascular access, the radiologist was unable to advance the access wire into the patient's artery.The access site was abandoned.Prior to discharge the radiologist ordered an ultrasound scan of the primary access site.The ultrasound study demonstrated that a piece of the access wire may have detached within the patients right femoral artery.The radiologist informed the patient and family of the situation and consulted with other vascular surgeons about leaving the unidentified foreign body within the patient's artery.Due to the fact the artery was already occluded, the foreign body could not cause patient injury.
Additional Manufacturer Narrative
The suspect device was not 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 COAXIAL MINI ACCESS KIT
• Common Device Name: MINI ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 9333517
• Report Number: 3011642792-2019-00023
• Device Sequence Number: 19359077
• Product Code: DRE
• UDI-Device Identifier: 00884450088791
• UDI-Public: 884450088791
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 02/28/2022
• Device Catalogue Number: MAK401-E/C
• Device Lot Number: I1523621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/17/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1