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

Model Number	402804
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
During an atrial fibrillation ablation, during the process of isolating the pulmonary veins and checking to ensure electrical block was successful, it was noted the catheter seemed to have lost its shape and was hard to manipulate within the left atrial chamber.The catheter was unable to be retrieved back through the sheath.A new catheter and a different sheath were used to advance into the left atrium and complete the procedure successfully.Upon removal, the catheter was still unable to pull back into the sheath to remove it from the body.Once the catheter was able to be removed (still within the sheath), it was noted that part of the catheter was broken off, leaving wire underneath and the outer insulation exposed.The outer plastic part of the catheter directly before the spiral was entirely broken off.The patient was stable with no patient consequences.
Additional Manufacturer Narrative
One reflexion spiral¿ variable radius catheter 6 f loop bi-directional, 7f was received for investigation.The reported shaft damage was confirmed.Visual inspection showed a fracture in the shaft at the spiral loop/shaft transition.Further investigation concluded that the fracture in the shaft was due to a weak bonding at the spiral loop/shaft transition.Actions have been taken to prevent further reoccurrence.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9457885
• Report Number: 2182269-2019-00250
• Device Sequence Number: 2159253
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 05/31/2022
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 7046336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1