MAUDE Adverse Event Report: ST. JUDE MEDICAL SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401450
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3008452825-2022-00441.During the procedure, the catheters became entangled with each other.While mapping in the right atrium, the hd grid catheter went into the right ventricle (rv) and the rv catheter (jsn) went through the opening between the splines of the hd grid catheter.The physician was unaware that the rv catheter went through the splines and pulled the hd grid catheter back into the sro sheath to remove it.When doing so, the jsn catheter was pulled into the sheath and pulled harder to remove hd grid.Fluoroscopy revealed the jsn catheter was doubled over and sticking out of the top of the sro sheath.Both catheters were stuck in the sheath.Tech services was contacted and while on the phone, the physician pushed and the two catheters finally came out the distal end of the sro and was able to remove the jsn, then the grid.Both catheters were intact, but bent.There was no harm to the patient and the procedure was completed successfully.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported entanglement remains unknown.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14518588
• Report Number: 3008452825-2022-00442
• Device Sequence Number: 12163769
• Product Code: DRF
• UDI-Device Identifier: 05414734201421
• UDI-Public: 05414734201421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K002976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 10/31/2024
• Device Model Number: 401450
• Device Catalogue Number: 401450
• Device Lot Number: 8215465
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID CATHETER, SE.
• Patient Sex: Unknown