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

Catalog Number SG24AC

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 07/12/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

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®
• Type of Device: 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
• MDR Text Key: 320199184
• Report Number: 1721504-2023-00068
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00884450246566
• UDI-Public: 884450246566
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: SG24AC
• Device Lot Number: H2582004728805728805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization