MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND MERIT S-MAK¿.COAXIAL MINI ACCESS KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	S-MAK501/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that a 77-year-old male had a dx-cag procedure on (b)(6) 2022.During the procedure, the operator had difficulty cannulating the right radial artery and after several failed attempts the right radial approach was abandoned, the left radial access attempt was successfully acquired.The procedure was successfully completed with no patient issues to report.The patient was discharged to home.Twelve months later, the patient presented on multiple occasions with ongoing pain and a non-healing wound at the site of his right radial access site.The patient had an ultrasound scan on (b)(6) 2022 and received 3 courses of antibiotics.On (b)(6) 2023 the presented again with pain and redness of the right arm.He was sent home the same day with a diagnosis of cellulitis and a 7-day course of antibiotics.The patient returned to the ed on (b)(6) 2023 because he was not responding to the antibiotics.The patient was systemically unwell and was admitted to the hospital for intravenous antibiotics and further imaging.On (b)(6) 2023, the physician was called to review his arm after showing the rn a piece of metal protruding from his right forearm.This event was escalated to the surgical department for an urgent computed tomography (ct) study.The ct revealed retained fragments [x3] of a metallic access guidewire.The patient underwent a foreign body removal procedure the same day and required a 15-day admission for intravenous antibiotics to treat a staph infection and the bacteremia caused by the retained guidewire.During a recent follow up visit, the patient had no evidence of ongoing infection.His inflammatory markers were normal and blood cultures were negative.
Additional Manufacturer Narrative
The suspect medical 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 later, the investigation will be reopened.

• Brand Name: MERIT S-MAK¿.COAXIAL MINI ACCESS KIT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 18984222
• Report Number: 3011642792-2024-00017
• Device Sequence Number: 8208838
• Product Code: DRE
• UDI-Device Identifier: 00884450012628
• UDI-Public: 884450012628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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-MAK501/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS SHEATH
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male