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

Catalog Number	WORLVI-75-5-62-07-RE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	08/12/2023
Type of Reportable Event	Death
Event or Problem Description
Customer reports a right ventricular lead was successfully placed, then an atrioventricular node ablation was performed.Lastly, coronary sinus (cs) access was gained with the worley system.While searching for a vein to implant the lv lead, the patients blood pressure dropped.An emergent echo was performed showing a pericardial effusion.A pericardiocentesis was initiated and fluid was pulled off the pericardium.The patient kept having pulseless electrical activity (pea) events and pulmonary resuscitation was initiated.Eventually the patient passed and time of death was called.In review of the flouro images, the wire was in the cs outside of the cardiac shadow.This was believed to be the cause of the effusion.Follow-up mdt rep communication: "yes, the worley was thought to be the cause.".
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: WORLEY¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.-ANG; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.-ANG; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 25243523
• Report Number: 3011642792-2026-00081
• Device Sequence Number: 10548469
• Product Code: DYB
• UDI-Device Identifier: 00884450169797
• UDI-Public: 00884450169797
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: WORLVI-75-5-62-07-RE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown