MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MERIT S-MAK.COAXIAL MINI ACCESS KIT; MICROPUNCTURE KIT

Catalog Number	S-MAK501/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Serious 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.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.
Event or Problem Description
The account alleges that during a transjugular intrahepatic portosystemic shunt [tips] procedure to connect the portal vein to the hepatic vein within the patient's liver, the tip of the micro access wire within the access kit detached within the patient's hepatic parenchyma.The foreign was successfully removed from the patient's venous system with no additional consequences to report.

• Brand Name: MERIT S-MAK.COAXIAL MINI ACCESS KIT
• Common Device Name: MICROPUNCTURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• MDR Report Key: 11739352
• Report Number: 3011642792-2021-00013
• Device Sequence Number: 14468354
• Product Code: DRE
• UDI-Device Identifier: 00884450012628
• UDI-Public: 884450012628
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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 Expiration Date: 11/29/2023
• Device Catalogue Number: S-MAK501/A
• Device Lot Number: I1941618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/28/2021
• 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: Required Intervention