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

Model Number	D402893
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
Toward the end of an atrial fibrillation procedure, slight resistance was noted when the catheter was removed from the patient.When the device was removed, the outer material on the catheter loop was frayed, exposing the internal components.Additionally, the electrodes were displaced from their original positions.No anomalies were noted while mapping.There were no adverse consequences to the patient.The devices are stored in their original packaging.
Additional Manufacturer Narrative
The reported damage was confirmed.One image was also received for evaluation.The image appears to show the damage to the spiral loop.Visual inspection found displaced electrodes, torn tubing on the shaft and spiral loop, and exposed wires.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage to the catheter is consistent with damage during use.

• Brand Name: REFLEXION SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER
• 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: 10195442
• Report Number: 2182269-2020-00060
• Device Sequence Number: 16875103
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: 05414734216654
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 01/31/2022
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 6821577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1