MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT S-MAK¿; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number S-MAK401N/C

Device Problems Entrapment of Device (1212); Material Separation (1562); Activation Problem (4042)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

1055 attempt arterial access for aline.Micropuncture wire unable to retrieve left femoral artery, manual pressure held, await dr (currently in cathlab case) and cerebral venous thrombosis (cvt) physician's assistant (pa) assistance.1104 dr and cvt pa arrive.1108 sheath and omniflush inserted right femoral artery for left femoral artery angiogram.1112 left femoral artery angiogram x 4 w/ multiple views.1126 attempt to remove existing micropuncture wire, partial wire retained.1128 clinical decision made between two doctors, cvt pa.1131 dr, cvt pa exit case.1131 dr proceed to ablation.1323 case end, nursing service management (nsm) aware, wire sequestered, new micropuncture kit given to nsm.1436 p.

• Brand Name: MERIT S-MAK¿
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 17198023
• MDR Text Key: 317872235
• Report Number: 17198023
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: S-MAK401N/C
• Device Lot Number: 12549433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2023
• Date Report to Manufacturer: 06/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male