MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. S-MAK COAXIAL MINI ACCESS KIT

Catalog Number	S-MAK401N/C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges during access for procedure (coronary arteriogram with possible intervention) the tip of the micropuncture wire sheared off.They noticed sheared tip when removing the micropuncture sheath and wire due to the placement being too low and needing to re-stick the access site.Several attempts made to snare/retrieve retained wire but were unsuccessful.Vascular surgery consulted and decision was made to bring patient emergently to vascular or for cutdown, exploration, and removal of retained wire.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was returned uncoiled however the root cause was not determined.The nature of the damage to the wire is consistent with excessive force during use or manipulation through the sheath/needle.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.This issue has been communicated to the associated manufacturing & engineering groups.

• Brand Name: S-MAK COAXIAL MINI ACCESS KIT
• Common Device Name: MINI ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana in?s de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22647407
• Report Number: 1721504-2025-00201
• Device Sequence Number: 8632504
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 00884450012635
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: S-MAK401N/C
• Device Lot Number: I3183595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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