MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SAFEGUARD®; CLAMP, VASCULAR

Catalog Number	SG24AC
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that there has been a life-threatening episode with one of their itu patients involving a safeguard compression device (24cm femoral).The device was defective after application, and the compression exerted to acquire hemostasis was inadequate.It looks like the balloon was punctured somehow and the device lost air quickly.When the hospital staff realized the situation four hours later, there was femoral bleeding discovered.The patient experienced cardiac arrest.A code was called, and cardiopulmonary resuscitation protocols were effective.
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 not returned for evaluation; however, unused devices from the same lot were returned by the customer.The devices functioned as expected.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: SAFEGUARD®
• Common Device Name: CLAMP, VASCULAR
• 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: 17438621
• Report Number: 1721504-2023-00068
• Device Sequence Number: 2531494
• Product Code: DXC
• UDI-Device Identifier: 00884450246566
• UDI-Public: 884450246566
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K062569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 11/10/2025
• Device Catalogue Number: SG24AC
• Device Lot Number: H2582004728805728805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown