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

Catalog Number	K21-00022
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a fistula procedure the clinician was attempting to use the ellipsys device during fistula procedure.It was alleged there was no vessel tortuosity, the artery diameter was 2.5mm and vein diameter was 3mm.The distance between artery and vein was not greater than 1.5mm.Ifu was followed.It is alleged that during the procedure while the catheter was being pulled back across the anastomosis, it did not catch on the arterial wall and was retracted into the vein at which point it became stuck.Neither the catheter nor the sheath would advance or retract.The catheter was rotated and at one point closed to try and help advance or retract, but was unsuccessful.The clinician used force to remove the catheter and sheath together while maintaining wire access.It is believed the catheter may have become stuck on a valve in the perforating vein.The account alleges that the device was stuck around the outside of the sheath and both had to be removed together.A small hematoma formed and a slightly larger exit hole was created in the anterior vein wall.This was resolved with prolonged pressure hold and a suture at the skin entry point.A new catheter and sheath were inserted over the original wire and the procedure was successfully completed.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.

• 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
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 13538920
• Report Number: 1721504-2022-00018
• Device Sequence Number: 4457264
• Product Code: OEX
• UDI-Device Identifier: 00884450412084
• UDI-Public: 884450412084
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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 Expiration Date: 06/15/2024
• Device Catalogue Number: K21-00022
• Device Lot Number: H2119871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown