MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ RETRIEVAL SYSTEM CATHETER; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	LSCR111
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a scheduled procedure.During the procedure, the physician was attempting to implant the right atrial leadless pacemaker (alp) however, the tethers would not release the alp, broke off from the catheter, and remained on the device.Retrieval of the alp was attempted; however, the snare broke on the catheter.The alp remains implanted with the broken tethers attached.Further information was requested however, was not provided.
Additional Manufacturer Narrative
Correction: this report is to retract report mfr: 2017865-2025-91212 submitted on 01 jul 2025.This is not a reportable event.All previously submitted information should be corrected to not applicable and null fields.
Additional Manufacturer Narrative
The reported event ¿we used retrieval catheter to try to retrieve device and the snares broke on that catheter¿ was confirmed.As received, a complete catheter was returned in one piece with a fractured cincher tube.Visual examination noted the braid wire was broken at the snare¿s distal end.X-ray examination did not find any anomalies with the exception of procedural damage.Functional test of the catheter could not be performed due to the catheter¿s as received condition.The cause of the reported event of snares broke was isolated to the catheter being damaged consistent with procedural damage.

• Brand Name: AVEIR¿ RETRIEVAL SYSTEM CATHETER
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22379412
• Report Number: 2017865-2025-91212
• Device Sequence Number: 8410726
• Product Code: MMX
• UDI-Device Identifier: 05415067034496
• UDI-Public: (01)05415067034496(10)10558662(17)251231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 12/31/2025
• Device Model Number: LSCR111
• Device Lot Number: 10558662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 08/08/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/08/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: Male