MAUDE Adverse Event Report: ST. JUDE MEDICAL REFLEXION SPIRAL VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	402804
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Towards the end of the procedure, as the device was removed, the tip of the shaft was fractured and a sharp wire was sticking out of the catheter.The internal wiring of the catheter cut through the covering of the catheter, exposing the wire.There were no adverse patient consequences.
Additional Manufacturer Narrative
One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.The returned device was examined and a fracture in the grey shaft at the shaft to loop transition and exposed shape wire were confirmed.The kinks in the hoop indicate excessive force was used on the catheter, resulting in the fractured shaft and exposed shape wire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured shaft is consistent with damage during use.

• Brand Name: REFLEXION SPIRAL VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 12120351
• Report Number: 2182269-2021-00056
• Device Sequence Number: 14643584
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062251
• 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): 10/01/2021

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: 01/31/2024
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 7809431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 93