MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ENDOAVF ACCESS KIT; CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT

Model Number	10884450412081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/11/2021
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 significant extravasation of blood flow occurred during use of an ellipsys catheter for patient treatment.It was reported that the needle came out of the perforator vein before puncturing the radial artery.The patient required an open incision to repair the blood flow outside of the vessel and had a surgical brachiobasilic avf successfully created.The patient required observation overnight.Once the patient was stable, the patient was released home.There was no further patient injury reported.
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 review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: ENDOAVF ACCESS KIT
• Common Device Name: CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12397087
• Report Number: 1721504-2021-00063
• Device Sequence Number: 14627376
• Product Code: OEX
• UDI-Device Identifier: 10884450412081
• UDI-Public: 10884450412081
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10884450412081
• Device Catalogue Number: K21-00022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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