MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D402865
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation / pulmonary vein contraction procedure, blood was noted at the catheter handle.Upon removal from the patient, a crack was noted at the distal end of the tip.
Additional Manufacturer Narrative
One decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Visual inspection found the shaft to be fractured at the spiral loop transition and the end cap to be out of place.During the initial complaint analysis, it was noted the end cap was slightly pulled away from the handles.The gap was confirmed, and the cap was removed to determine the cause.The appropriate amount of adhesive was found in the cap, however one handle pin was broken off, indicating excessive torque/force on the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the shaft fracture and out of place end cap is consistent with damage during use.

• Brand Name: REFLEXION SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 11893256
• Report Number: 2182269-2021-00052
• Device Sequence Number: 3710102
• Product Code: DRF
• UDI-Device Identifier: 05414734206211
• UDI-Public: 05414734206211
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 09/30/2023
• Device Model Number: D402865
• Device Catalogue Number: D402865
• Device Lot Number: 7693459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1