MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. EMPOWER RETRIEVAL DEVICE

Catalog Number	668784-300
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during an the extraction procedure after a dual chamber transvenous icd, the leadless pacemaker was not able to be snared by the retrieval system with either the single or multi-loop snares, due to suspected encapsulation of the device.Therefore, the leadless pacemaker (lcp) was programmed off and was abandoned.It was noted the procedure was prolonged by at least an hour with the unsuccessful efforts to retrieve the lcp.No adverse patient effects were reported.Multiple attempts at snaring the empower pacemaker were attempted with both the single and multi-loop snares.Procedure was abandoned.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was 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.

• Brand Name: EMPOWER RETRIEVAL DEVICE
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer Contact: adrian cole ; 1600 west merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 22384430
• Report Number: 1721504-2025-00138
• Device Sequence Number: 8818229
• Product Code: MMX
• UDI-Device Identifier: 00884450269206
• UDI-Public: 00884450269206
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 668784-300
• Device Lot Number: K2395042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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
• Patient Sex: Unknown