MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. WORLEY¿ ADV. LVI; INTRODUCER, CATHETER

Catalog Number	WORLVI-75-5-62-55-RE/A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during placement of a dual access introducer (dai-trc), while advancing the worley advanced selective introducer toward the coronary sinus tributary, the distal tip of the device detached.An amplatz goose neck snare system was introduced to capture the detached segment.During retrieval, the tip fragmented further, and one portion migrated toward the pulmonary artery.Due to the risk of additional fragmentation and potential vessel injury, retrieval efforts were discontinued, and two fragments of the worley introducer tip were left in situ.Following the event, the physician noted that a retained fragment in the coronary sinus caused thrombosis of a coronary sinus tributary, and another fragmented portion had migrated into the segmental pulmonary artery, posing a risk for thrombosis.The patient was placed on lifelong anticoagulation therapy.The procedure was performed via a venous approach.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.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.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: WORLEY¿ ADV. LVI
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23405387
• Report Number: 1721504-2025-00573
• Device Sequence Number: 14681611
• Product Code: DYB
• UDI-Device Identifier: 00884450483954
• UDI-Public: 00884450483954
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K152116
• 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): 11/18/2025

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: 10/10/2025
• Device Catalogue Number: WORLVI-75-5-62-55-RE/A
• Device Lot Number: I2516827
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2022
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown