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

Model Number	LSCR111
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: (b)(4).It was reported the patient presented for a pacemaker replacement procedure.During surgery, the leadless pacemaker (lp) exhibited high capture thresholds after being tethered.During retrieval of the lp, the snare on the retrieval catheter loosened and the lp migrated to the pulmonary artery.The lp was successfully explanted and replaced.There were no patient consequences.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17981343
• Report Number: 2017865-2023-50315
• Device Sequence Number: 2453747
• Product Code: MMX
• UDI-Device Identifier: 05415067034496
• UDI-Public: 05415067034496
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 01/31/2024
• Device Model Number: LSCR111
• Device Lot Number: 8770054
• Was Device Available for Evaluation?: No
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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