MAUDE Adverse Event Report: MERIT MEDICAL IRELAND, LTD. ONE SNARE®; INTRAVASCULAR CATHETER-SNARE

Catalog Number	ONE2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
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 review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
A lead extraction procedure commenced to remove a rv lead due to fracture.The lead was prepped with a spectranetics lld to provide traction.Beginning with a spectranetics 13f tightrail rotating dilator sheath, the lead broke near the svc coil.The tightrail was removed from the body, and the decision was made to snare from the groin.A gore medical 20f dryseal flex introducer sheath was used with an abbott agilis steerable introducer.A merit medical one snare and merit medical wholey guidewire were initially used for snaring.The wholey wire broke, so then used a boston scientific superstiff amplatz guidewire to attempt to grab the lead.After unsuccessful attempts to pull and extract, snaring continued with the amplatz wire and merit medical one snare.The lead was pulled through the sheath, the one snare was disengaged, and was ran over both ends of the wire at the point of the lead.After successfully grasping the lead, he pulled down until the lead dislodged from the vasculature.The svc coil broke into two and remained in the svc.The remaining portion of the lead broke off and stayed intact at the distal end.Then, using the one snare, the loose end of the lead was pulled until it released.He was able to remove the entire portion through the snare and dryseal flew introducer sheath, other than the svc coil portion that had broken off earlier in the case.Once released, pressure declined, and an rv perforation was suspected.Tee was checked and identified pericardial tamponade.Pericardiocentesis was performed and aspirated fluid.The blood pressure increased, and the injury began to clot.Aspiration continued and the patient stabilized.Shortly after, the blood pressure decreased again, and ct surgeon came in to look at the clot and decided to leave and monitor in the icu.Patient was discharged to the icu for monitoring; the needle was left in the patient in case further aspiration was needed.Patient was stable, alert and awake without the need for pain meds a few hours following the pericardiocentesis.The patient survived the procedure.The physician stated that the act of pulling on the lead via femoral snare attributed to the perforation.

• Brand Name: ONE SNARE®
• Common Device Name: INTRAVASCULAR CATHETER-SNARE
• Manufacturer (Section D): MERIT MEDICAL IRELAND, LTD.; parkmore business park west; ballybrit, galway H91W2 74; EI H91W274
• Manufacturer (Section G): MERIT MEDICAL IRELAND, LTD.; parkmore business park west; ballybrit, galway H91W2 74; EI H91W274
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23810469
• Report Number: 1721504-2025-00731
• Device Sequence Number: 15358921
• Product Code: MMX
• UDI-Device Identifier: 00884450094891
• UDI-Public: 00884450094891
• Combination Product (Y/N): N
• PMA/510(K) Number: K122088
• 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): 12/15/2025

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?: No
• Device Catalogue Number: ONE2000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/15/2025
• 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: Required Intervention
• Patient Sex: Unknown