MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KITS; ANGIOGRAPHY/ANGIOPLASTY KIT

Catalog Number	K12T-11982
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that post radio frequency [rf] ablation procedure, the physician noticed the access dilator had detached within the patient's great saphenous vein.The physician noticed the access sheath dilator had detached at the hub and was inadvertently pushed further into the patient's gsv by the physician during the ablation processes.The rf ablation procedure was successfully completed when the physician first noticed the missing dilator, so the foreign body did not prevent the successful rf ablation treatment for this patient.A follow-up ultrasound study verified that the foreign body was still within the patient's venous system and that the more proximal part of the vein had been decimated by the rf ablation procedure so there was no risk of further migration.The patient is currently asymptomatic and the physician is not interested in surgical retrieval of the foreign body.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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 at a later date, the investigation will be reopened.

• Brand Name: MERIT CUSTOM KITS
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 19221371
• Report Number: 1125782-2024-00001
• Device Sequence Number: 15193824
• Product Code: OEQ
• UDI-Device Identifier: 00884450581322
• UDI-Public: 00884450581322
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: K12T-11982
• Device Lot Number: T2823698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/18/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown